FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K820132 |
3M COMPANY |
BABYBIRD 2 VENTILATOR |
01/28/1982 |
K900744 |
ACUTRONIC MEDICAL SYSTEMS AG |
AMS 3000 PORTABLE JET VENTILATOR |
04/29/1991 |
K883865 |
ACUTRONIC MEDICAL SYSTEMS AG |
EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 |
06/08/1989 |
K012693 |
ACUTRONIC MEDICAL SYSTEMS AG |
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES |
08/01/2002 |
K012691 |
ACUTRONIC MEDICAL SYSTEMS AG |
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES |
12/20/2002 |
K863155 |
ACUTRONIC MEDICAL SYSTEMS AG |
UNIVERSAL JET VENTILATOR MODEL AMS-1000 |
09/28/1987 |
K900745 |
ACUTRONIC MEDICAL SYSTEMS AG |
VS-200S JET VENTILATOR |
04/29/1991 |
K903010 |
AEQUITRON MEDICAL, INC. |
CONTINUOUS VOLUME VENTILATOR MODEL LP10 |
11/30/1990 |
K914424 |
AEQUITRON MEDICAL, INC. |
MODEL 6213 REMOTE ALARM |
09/10/1992 |
K952880 |
AEQUITRON MEDICAL, INC. |
MODEL LP-1000 VOLUME VENTILATOR |
06/20/1996 |
K905244 |
AEQUITRON MEDICAL, INC. |
MODEL LP6 VENTILATOR, MODIFICATION |
11/30/1990 |
K760663 |
AIR-SHIELDS, INC. |
MVP-10 PEDIATRIC/NEONATAL VENTILATOR |
09/27/1976 |
K822456 |
AIRCO/OHIO MEDICAL PRODUCTS |
OHIO V5A ANESTHESIA VENTILATOR |
09/21/1982 |
K790809 |
AIRCO/OHIO MEDICAL PRODUCTS |
VS, ANESTHESIA VENTILATOR |
05/04/1979 |
K043085 |
AIRON CORPORATION |
MODIFICATION TO: PNEUTON VENTILATOR |
12/20/2004 |
K121379 |
AIRON CORPORATION |
PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY |
10/11/2012 |
K024344 |
AIRON CORPORATION |
PNEUTON VENTILATOR |
06/03/2003 |
K032922 |
AIRWAYS LTD., INC. |
CLARISSA INFANT NCPAP CANNULA |
09/22/2004 |
K972203 |
ALLIED HEALTHCARE PRODUCTS, INC. |
BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT |
11/06/1997 |
K955865 |
ALLIED HEALTHCARE PRODUCTS, INC. |
BEAR CUB INFANT PRESSURE VENTILATOR |
08/06/1996 |
K983981 |
BEAR MEDICAL SYSTEMS, INC. |
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE |
11/20/1998 |
K881335 |
BEAR MEDICAL SYSTEMS, INC. |
BEAR 3 VENTILATOR |
08/04/1988 |
K841279 |
BEAR MEDICAL SYSTEMS, INC. |
BEAR 33 |
05/23/1984 |
K912619 |
BEAR MEDICAL SYSTEMS, INC. |
BEAR 7 VENTILATOR |
06/11/1992 |
K900637 |
BEAR MEDICAL SYSTEMS, INC. |
BEAR CEM CONTROLLER |
08/03/1990 |
K992788 |
BEAR MEDICAL SYSTEMS, INC. |
BEAR CUB 750 PSV |
09/16/1999 |
K882764 |
BEAR MEDICAL SYSTEMS, INC. |
BEAR EVC-100 CONTROLLER |
09/30/1988 |
K871985 |
BEAR MEDICAL SYSTEMS, INC. |
BEAR JET VENTILATOR FOR USE DURING (ESWL) |
06/15/1987 |
K842688 |
BEAR MEDICAL SYSTEMS, INC. |
BEAR JET-150 VENTILATOR |
07/26/1984 |
K840119 |
BEAR MEDICAL SYSTEMS, INC. |
CONTINUOUS VENTILATOR |
04/06/1984 |
K842363 |
BEAR MEDICAL SYSTEMS, INC. |
PENLON ANESTHESIA VENTILATOR SERIES 300 |
06/26/1984 |
K842362 |
BEAR MEDICAL SYSTEMS, INC. |
PENLON TRANSPORT VENTILATOR SERIES 350 |
06/26/1984 |
K942938 |
BIO-MED DEVICES, INC. |
CROSSVENT-4 VENTILATOR |
09/19/1995 |
K823861 |
BIO-MED DEVICES, INC. |
ET-3 EMERGENCY TRANSPORT VENTILATOR |
02/07/1983 |
K801890 |
BIO-MED DEVICES, INC. |
IC-2 VENTILATOR |
11/18/1980 |
K896380 |
BIO-MED DEVICES, INC. |
IC-2A MRI ADULT/PEDIATRIC VENTILATOR |
02/12/1990 |
K813253 |
BIO-MED DEVICES, INC. |
IC-5 VENTILATOR |
12/09/1981 |
K896381 |
BIO-MED DEVICES, INC. |
MVP-10 MRI INFANT VENTILATOR |
02/12/1990 |
K830230 |
BIO-MED DEVICES, INC. |
PROGRAMMABLE VENTILATOR |
02/09/1983 |
K173973 |
Bio-Med Devices, Inc. |
TV-100 |
07/20/2018 |
K800125 |
BIO-MED DEVICES, INC. |
VENTILATOR TEST LUNG |
01/24/1980 |
K812980 |
BIO-MEDICAL REPAIR, INC. |
MA-2 VENTILATOR |
11/06/1981 |
K853760 |
BIO-TEK INSTRUMENTS, INC. |
ADULT VENTILATOR TESTER VT-1 |
12/03/1985 |
K921821 |
BIOMAGNETIC TECHNOLOGIES, INC. |
IBT MODEL SVI |
11/02/1992 |
K880721 |
BIRD PRODUCTS CORP. |
6400ST INTERFACE MODULE-RS232 |
04/14/1988 |
K894322 |
BIRD PRODUCTS CORP. |
8400ST VOLUME VENTILATOR |
01/29/1990 |
K013642 |
BIRD PRODUCTS CORP. |
AVEA |
05/22/2002 |
K802087 |
BIRD PRODUCTS CORP. |
BABYBIRD 2 VENTILATOR |
10/03/1980 |
K863228 |
BIRD PRODUCTS CORP. |
BIRD 6400ST VOLUME VENTILATOR |
02/10/1987 |
K921387 |
BIRD PRODUCTS CORP. |
BIRD 8400ST ADULT VOLUME VENTILATOR |
03/11/1993 |
K930747 |
BIRD PRODUCTS CORP. |
BIRD 8400TI ADULT VOLUME VENTILATOR |
02/15/1994 |
K022674 |
BIRD PRODUCTS CORP. |
BIRD AVEA VENTILATOR |
11/06/2002 |
K933262 |
BIRD PRODUCTS CORP. |
BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903 |
07/29/1993 |
K920113 |
BIRD PRODUCTS CORP. |
BIRD GRAPHICS MONITOR |
02/19/1993 |
K982580 |
BIRD PRODUCTS CORP. |
BIRD MONITOR INTERFACE |
10/22/1998 |
K911336 |
BIRD PRODUCTS CORP. |
BIRD NEBULIZATION SYNCHRONIZER |
11/29/1991 |
K003770 |
BIRD PRODUCTS CORP. |
BIRD TBIRD LEGACY VENTILATOR |
12/15/2000 |
K032451 |
BIRD PRODUCTS CORP. |
BIRD TBIRD VELA VENTILATOR |
03/17/2004 |
K020746 |
BIRD PRODUCTS CORP. |
BIRD TBIRD VELA VENTILATOR |
04/22/2002 |
K993449 |
BIRD PRODUCTS CORP. |
BIRD V.I.P. GOLD/STERLING |
12/20/1999 |
K915488 |
BIRD PRODUCTS CORP. |
PEDIATRIC VENTILATOR AND PARTNER VOLUME MONITOR |
10/22/1992 |
K950484 |
BIRD PRODUCTS CORP. |
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR |
05/03/1996 |
K981971 |
BIRD PRODUCTS CORP. |
TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 |
08/24/1998 |
K895541 |
BIRD PRODUCTS CORP. |
V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR |
03/08/1990 |
K914485 |
BIRD PRODUCTS CORP. |
VENTILATOR STAND |
10/25/1991 |
K982132 |
BLEASE MEDICAL EQUIPMENT LTD. |
BLEASE 6200 ANAESTHESIA VENTILATOR |
04/15/1999 |
K802118 |
BOURNS MEDICAL SYSTEMS, INC. |
BEAR 2 ADULT VOL. VENTILATOR |
10/03/1980 |
K801697 |
BOURNS MEDICAL SYSTEMS, INC. |
MODEL BP-200 INFANT PRESSURE VENTILATOR |
08/07/1980 |
K791186 |
BOURNS MEDICAL SYSTEMS, INC. |
MODEL BP-2000 TIME-CYCLED VENTILATOR |
07/06/1979 |
K802051 |
BOURNS MEDICAL SYSTEMS, INC. |
NEWBOURNS INFANT VENTILATOR |
10/03/1980 |
K790199 |
BOURNS MEDICAL SYSTEMS, INC. |
VENTILATOR MODEL BV-300 INFANT |
04/13/1979 |
K141943 |
BREATHE TECHNOLOGIES |
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM |
06/12/2015 |
K170037 |
Breathe Technologies |
Breathe Technologies Life2000Ö Ventilation System |
08/11/2017 |
K812958 |
CAIRCO LTD. |
EAST-FREEMAN VENTILATOR MARK 2 |
01/07/1982 |
K812953 |
CAIRCO LTD. |
RADCLIFFE VENTILATOR MARK 5 |
11/27/1981 |
K812961 |
CAIRCO LTD. |
SHEFFIELD INFANT VENTILATOR MARK 4 |
03/26/1982 |
K081837 |
CARDINAL HEALTH 207, INC. |
AVEA VENTILATOR |
08/13/2008 |
K081670 |
CARDINAL HEALTH 207, INC. |
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK |
10/09/2008 |
K093094 |
CARDINAL HEALTH 207, INC. |
VELA VENTILATOR |
05/11/2010 |
K990429 |
CARDIOPULMONARY CORP. |
MODIFICATION OF VENTURI VENTILATOR |
02/24/1999 |
K943412 |
CARDIOPULMONARY CORP. |
VENTURI VENTILATOR |
10/16/1995 |
K982174 |
CARDIOPULMONARY CORP. |
VENTURI VENTILATOR |
06/24/1998 |
K103211 |
CAREFUSION |
AVEA VENTILATOR |
05/12/2011 |
K101643 |
CAREFUSION |
MODEL LTV 1100 VENTILATOR |
01/26/2011 |
K981412 |
CLARY CORP. |
M1145 (UPS1-1.25K-1G-MP) UPS |
11/23/1998 |
K960861 |
CORE-M, INC. |
OMICRON MONITOR, DELTA MONITOR |
08/19/1996 |
K120146 |
COSMED S.R.L. |
QUARK SERIES |
12/11/2012 |
K131252 |
COVIDIEN |
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM |
02/24/2014 |
K162738 |
Covidien |
Puritan Bennett 980 Ventilator System |
10/27/2017 |
K151252 |
Covidien LP |
Puritan Bennett 840 Series Ventilator System |
03/29/2016 |
K082966 |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. |
PB 540 VENTILATOR |
10/31/2008 |
K083693 |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. |
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 |
04/02/2009 |
K092847 |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION |
03/11/2010 |
K111116 |
DATEX-OHMEDA |
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 |
09/09/2011 |
K093886 |
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
ENGSTROM CARESTATION, ENGSTROM PRO |
05/03/2010 |
K142679 |
Datex-Ohmeda, Inc. |
CARESCAPE R860 |
06/12/2015 |
K023366 |
DATEX-OHMEDA, INC. |
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS |
10/07/2003 |
K140575 |
DATEX-OHMEDA, INC. |
ENGSTROM CARESTATION, ENGSTROM PRO |
02/03/2015 |
K081842 |
DATEX-OHMEDA, INC. |
ENGSTROM CARESTATION, ENGSTROM PRO |
10/03/2008 |
K050860 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR |
06/21/2005 |
K051895 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
09/27/2005 |
K060862 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
06/05/2006 |
K062710 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
12/08/2006 |
K041775 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
10/26/2004 |
K050597 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
03/25/2005 |
K041524 |
DATEX-OHMEDA, INC. |
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM |
09/20/2004 |
K771039 |
DEPT. OF THE NAVY |
RESPIRATOR, PROTABLE, VOLUME CONTROLLED |
08/05/1977 |
K871448 |
DEVELOPMED CORP. |
MODEL 105 VENTILATOR |
05/07/1987 |
K072885 |
DRAEGER MEDICAL AG & CO. KG |
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 |
04/07/2008 |
K081743 |
DRAEGER MEDICAL AG & CO. KG |
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS |
09/22/2008 |
K083050 |
DRAEGER MEDICAL AG & CO. KG |
EVITE XL |
12/29/2008 |
K093633 |
DRAEGER MEDICAL AG & CO. KG |
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE |
03/30/2010 |
K060705 |
DRAEGER MEDICAL B.V. |
CARINA HOME |
06/14/2006 |
K082600 |
DRAEGER MEDICAL B.V. |
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) |
11/26/2008 |
K121886 |
DRAEGER MEDICAL GMBH |
SAVINA 300 SAVINA 300, COUNTRY VARIANTS |
08/08/2014 |
K103625 |
Draeger Medical Systems, Inc. |
OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE |
10/06/2011 |
K874371 |
DRAEGER MEDICAL, INC. |
ASCENDING VENTILATOR BELLOWS |
12/11/1987 |
K980208 |
DRAEGER MEDICAL, INC. |
DIVAN ANESTHESIA VENTILATOR |
08/04/1998 |
K802168 |
DRAEGER MEDICAL, INC. |
DRAGER AV2 ANESTHESIA VENTILATOR |
12/20/1980 |
K912533 |
DRAEGER MEDICAL, INC. |
NARKOMED AV-E VENTILATOR |
07/25/1991 |
K953228 |
DRAEGER MEDICAL, INC. |
NARKOMED AV2+ ANESTHESIA VENTILATOR |
03/01/1996 |
K873549 |
DRAEGER MEDICAL, INC. |
PEDIATRIC BELLOWS |
10/08/1987 |
K864431 |
DRAEGER MEDICAL, INC. |
PEDIATRIC BELLOWS |
01/12/1987 |
K874415 |
DRAEGER MEDICAL, INC. |
PRESSURE LIMIT CONTROL |
01/11/1988 |
K040642 |
DRAEGET MEDICAL AG & CO. KGAA |
LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA |
06/02/2004 |
K051263 |
DRAGER MEDICAL AG & CO. KGAA |
EVITAXL WITH OPTION SMARTCARE |
07/12/2005 |
K093632 |
DRAGER MEDICAL AG & CO. KGAA |
INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE |
04/05/2010 |
K072412 |
DRAGER MEDICAL AG & CO. KGAA |
OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 |
02/06/2008 |
K062267 |
DRAGER MEDICAL B.V. |
OXYLOG 3000 |
10/31/2006 |
K010093 |
DRAGER MEDIZINTECHNIK GMBH |
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 |
06/14/2001 |
K023289 |
DRAGER MEDIZINTECHNIK GMBH |
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 |
01/15/2003 |
K010793 |
DRAGER MEDIZINTECHNIK GMBH |
OXYLOG 1000, MODEL 2M86840 |
12/20/2001 |
K003068 |
DRAGER MEDIZINTECHNIK GMBH |
SAVINA |
06/25/2001 |
K012177 |
DRAGER MEDIZINTECHNIK GMBH |
VENTVIEW, MODEL 8414095 |
09/04/2001 |
K992608 |
DRAGER, INC. |
ATC OPTION FOR EVITA 2 DURA AND EVITA 4 |
08/24/1999 |
K903089 |
DRAGER, INC. |
BABYLOG 8000 INFANT VENTILATOR |
06/10/1991 |
K926292 |
DRAGER, INC. |
BABYLOG 8000 INFANT VENTILATOR |
04/19/1994 |
K974176 |
DRAGER, INC. |
BABYLOG 8000 PLUS |
06/17/1998 |
K953238 |
DRAGER, INC. |
DRAGER MICRO VENT |
09/16/1996 |
K984577 |
DRAGER, INC. |
DRAGER OXYLOG 2000 |
01/22/1999 |
K924930 |
DRAGER, INC. |
EVITA |
01/10/1994 |
K970165 |
DRAGER, INC. |
EVITA 2 DURA |
08/26/1997 |
K961687 |
DRAGER, INC. |
EVITA 4 |
12/13/1996 |
K980642 |
DRAGER, INC. |
EVITA 4 (8411900) |
09/04/1998 |
K983219 |
DRAGER, INC. |
NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 |
12/07/1998 |
K950853 |
DRAGER, INC. |
OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS |
11/05/1996 |
K943531 |
DRAGER, INC. |
OXYLOG 2000 |
08/25/1995 |
K180779 |
Dragerwerk AG & CO. KGaA |
Savina 300 |
01/17/2019 |
K880923 |
DRYDEN CORP. |
PATIENT VENTILATOR ISOLATOR |
09/06/1988 |
K792564 |
EASTERN ANESTHESIA, INC. |
MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR |
12/19/1979 |
K802270 |
EASTERN ANESTHESIA, INC. |
PROTECTIVE BAR FOR THE MA-1VENTILATOR |
10/03/1980 |
K021112 |
EVENT MEDICAL LTD |
INSPIRATION VENTILATOR SYSTEM |
11/22/2002 |
K130178 |
EVENT MEDICAL LTD |
INSPIRATION VENTILATOR SYSTEM 5I/7I |
10/29/2013 |
K030341 |
EVENT MEDICAL LTD |
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM |
01/16/2004 |
K051550 |
EVENT MEDICAL LTD. |
INSPIRATION VENTILATOR SYSTEM |
07/12/2005 |
K113743 |
EVENT MEDICAL, INC. |
EVOLUTION 3E VENTILATOR |
12/18/2012 |
K072590 |
EVENT MEDICAL, INC. |
INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM |
01/04/2008 |
K901953 |
FERGUSON MEDICAL |
AIROX AXR. 1A |
01/02/1991 |
K083122 |
FISHER & PAYKEL HEALTHCARE, LTD. |
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 |
03/04/2009 |
K173060 |
Fisher and Paykel Healthcare Limited |
F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version |
01/25/2018 |
K143035 |
FLIGHT MEDICAL INNOVATIONS LTD. |
Flight 60 Ventilator |
03/30/2016 |
K120726 |
FLIGHT MEDICAL INNOVATIONS LTD. |
FLIGHT 60 VENTILATOR |
07/06/2012 |
K111683 |
FLIGHT MEDICAL INNOVATIONS LTD. |
FLIGHT 60 VENTILATOR |
10/31/2011 |
K130171 |
FLIGHT MEDICAL INNOVATIONS LTD. |
FLIGHT 60 VENTILATOR |
04/08/2014 |
K100753 |
FLIGHT MEDICAL LTD. |
FLIGHT 60 VENTILATOR, MODEL F-60 |
08/20/2010 |
K822040 |
FRASER HARLAKE, INC. |
POWERED EMERGENCY VENTILATOR |
08/19/1982 |
K862025 |
GAMBRO, INC. |
ENGSTROM ERICA II RESPIRATOR |
06/18/1986 |
K872482 |
GAMBRO, INC. |
GAMBRO-ENGSTROM ERICA IV RESPIRATOR |
03/03/1988 |
K061090 |
HAMILTON MEDICAL AG |
GALILEO GOLD ASV |
07/17/2006 |
K120574 |
HAMILTON MEDICAL AG |
HAMILTON-C1 |
05/30/2012 |
K102775 |
HAMILTON MEDICAL AG |
HAMILTON-C2 |
01/21/2011 |
K090468 |
HAMILTON MEDICAL AG |
HAMILTON-C2 |
06/15/2009 |
K121225 |
HAMILTON MEDICAL AG |
HAMILTON-C2 |
11/16/2012 |
K092148 |
HAMILTON MEDICAL AG |
HAMILTON-C2 |
03/04/2010 |
K161450 |
HAMILTON MEDICAL AG |
HAMILTON-C3 |
04/27/2017 |
K123637 |
HAMILTON MEDICAL AG |
HAMILTON-C3 |
12/21/2012 |
K103803 |
HAMILTON MEDICAL AG |
HAMILTON-G5 |
11/23/2011 |
K070513 |
HAMILTON MEDICAL AG |
HAMILTON-G5 |
11/26/2007 |
K131774 |
HAMILTON MEDICAL AG |
HAMILTON-G5 |
10/09/2013 |
K193228 |
Hamilton Medical AG |
Hamilton-G5 |
05/04/2020 |
K122438 |
HAMILTON MEDICAL AG |
HAMILTON-MR1 |
11/20/2013 |
K153046 |
HAMILTON MEDICAL AG |
HAMILTON-MR1 |
09/06/2016 |
K120670 |
HAMILTON MEDICAL AG |
HAMILTON-T1 |
04/03/2012 |
K181216 |
Hamilton Medical AG |
HAMILTON-T1, HAMILTON-C1 |
08/02/2019 |
K140939 |
HAMILTON MEDICAL AG |
HAMILTON-T1,HAMILTON-C1 |
09/02/2015 |
K112006 |
HAMILTON MEDICAL AG |
HAMILTON-TC1 |
02/09/2012 |
K080181 |
HAMILTON MEDICAL AG |
MODIFICATION TO GALILEO GOLD |
06/24/2008 |
K081521 |
HAMILTON MEDICAL AG |
MODIFICATION TO HAMILTON-G5 |
09/25/2008 |
K022679 |
HAMILTON MEDICAL AG |
RAPHAEL |
10/22/2003 |
K052863 |
HAMILTON MEDICAL AG |
RAPHAEL COLOR |
01/06/2006 |
K071194 |
HAMILTON MEDICAL AG |
RAPHAEL COLOR ASV VENTILATOR |
10/18/2007 |
K894316 |
HAMILTON MEDICAL, INC. |
AMADEUS VENTILATOR |
09/22/1989 |
K040574 |
HAMILTON MEDICAL, INC. |
GALILEO GOLD |
10/27/2004 |
K001686 |
HAMILTON MEDICAL, INC. |
GALILEO VENTILATOR |
06/23/2000 |
K982910 |
HAMILTON MEDICAL, INC. |
HAMILTON MEDICAL GALILEOVENTILATOR |
09/14/1999 |
K894426 |
HAMILTON MEDICAL, INC. |
LEONARDO INFORMATION SYSTEM |
09/26/1989 |
K900465 |
HAMILTON MEDICAL, INC. |
MAX TRANSPORT VENTILATOR |
06/18/1990 |
K861432 |
HAMILTON MEDICAL, INC. |
VEOLAR VENTILATOR |
05/06/1986 |
K871792 |
HAMILTON MEDICAL, INC. |
VEOLAR VENTILATOR |
04/21/1988 |
K881482 |
HAMILTON MEDICAL, INC. |
VEOLAR VENTILATOR |
06/16/1988 |
K901448 |
HAMILTON MEDICAL, INC. |
VEOLAR VENTILATOR |
12/20/1991 |
K180295 |
Hamiton Medical AG |
Hamilton-G5 |
07/30/2019 |
K030515 |
HANS RUDOLPH, INC. |
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS |
05/02/2003 |
K853300 |
HEALTHDYNE, INC. |
HEALTHDYNE IMPLUSE VENTILATOR |
08/15/1985 |
K840345 |
HEALTHDYNE, INC. |
IMPULSE VENTILATOR |
02/23/1984 |
K841818 |
HEALTHDYNE, INC. |
IMPULSE VENTILATOR |
06/05/1984 |
K802583 |
HEALTHDYNE, INC. |
INFANT VENTILATOR, (RESPIRATOR) PLAN B |
12/18/1980 |
K813254 |
HEALTHDYNE, INC. |
JET VENTILATOR |
02/04/1982 |
K781926 |
HEALTHDYNE, INC. |
VENTILATOR, INFANT MODEL 100 |
12/21/1978 |
K810893 |
HEWLETT-PACKARD CO. |
HEWLETT-PACKARD VENTILATOR |
06/18/1981 |
K853501 |
HONEYWELL, INC. |
HONEYWELL ELECTRONIC VENTILATOR EV-A |
04/04/1986 |
K800650 |
HOSPAL MEDICAL CORP. |
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM |
04/02/1980 |
K102120 |
HSINER CO., LTD. |
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 |
08/12/2011 |
K111473 |
IMPACT INSTRUMENTATION, INC. |
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR |
02/16/2012 |
K103318 |
IMPACT INSTRUMENTATION, INC. |
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR |
04/07/2011 |
K071526 |
IMPACT INSTRUMENTATION, INC. |
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV |
12/10/2008 |
K870861 |
IMPACT INSTRUMENTATION, INC. |
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR |
01/19/1988 |
K091238 |
IMPACT INSTRUMENTATION, INC. |
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ |
08/13/2009 |
K183364 |
Imtmedical AG |
Bellavista |
09/13/2019 |
K163127 |
IMTMEDICAL AG |
bellavista 1000 |
07/31/2017 |
K872466 |
INFRASONICS CORP. |
ADULT STAR |
07/08/1988 |
K905272 |
INFRASONICS CORP. |
ADULT STAR, MODIFICATION |
01/30/1991 |
K943106 |
INFRASONICS CORP. |
ADULT VENTILATOR |
12/28/1995 |
K923704 |
INFRASONICS CORP. |
INFANT STAR SERIES 500 |
10/22/1992 |
K840865 |
INFRASONICS CORP. |
INFANT STAR VENTILATOR |
04/30/1984 |
K911804 |
INFRASONICS CORP. |
INFRASONICS VENTILATOR "ADULT STAR", MODIFICATION |
06/11/1992 |
K922477 |
INFRASONICS CORP. |
MODEL 105 VENTILATOR, MODIFICATION |
08/24/1992 |
K884521 |
INFRASONICS CORP. |
STAR SYNC |
06/08/1989 |
K913972 |
INFRASONICS CORP. |
STAR SYNC, MODIFICATION |
01/09/1992 |
K922654 |
INFRASONICS CORP. |
VENTILATOR "ADULT STAR" MODIFICATION |
12/01/1992 |
K062019 |
INNOMED TECHNOLOGIES INC./RESPCARE INC. |
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD |
08/17/2006 |
K822113 |
INSPIR AID |
INSPIRAID VA-1 VENTILATOR |
08/31/1982 |
K812016 |
INSTRUMENT DEVELOPMENT CORP. |
VS600 JET VENTILATOR |
12/30/1981 |
K992670 |
INSTRUMENTATION INDUSTRIES, INC. |
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 |
09/17/1999 |
K864379 |
J. H. EMERSON CO. |
EMERSON 3MV VOLUME VENTILATOR |
12/15/1986 |
K862712 |
J. H. EMERSON CO. |
EMERSON MODEL 3HV COMPACT VENTILATOR |
09/18/1986 |
K822233 |
KONTRON INSTRUMENTS, INC. |
ABT 4000 VENTILATOR |
08/27/1982 |
K082351 |
LEVEL-5, INC. |
NEPTUNE HYPERBARIC VENTILATOR |
01/02/2009 |
K842122 |
LIFE PRODUCTS, INC. |
4A |
01/18/1985 |
K844179 |
LIFE PRODUCTS, INC. |
LP-5 |
01/18/1985 |
K844081 |
LIFE PRODUCTS, INC. |
LP4 VENTILATOR |
01/16/1985 |
K770132 |
LIFE PRODUCTS, INC. |
MODEL LP-3 PORTABLE VOLUME VENTILATOR |
02/01/1977 |
K791188 |
LIFECARE SERVICES, INC. |
CAM-10 BATTERY PACK (#7-001) |
07/05/1979 |
K800999 |
LIFECARE SERVICES, INC. |
CAM-10 EXSUFFLATION BELT #11-001 |
05/28/1980 |
K791033 |
LIFECARE SERVICES, INC. |
CAM-10 PVV PORTABLE VOLUME VENTILATOR |
07/03/1979 |
K862212 |
LIFECARE SERVICES, INC. |
LIFECARE REMOTE ALARM #34-001 |
06/23/1986 |
K913423 |
LIFECARE SERVICES, INC. |
LIFECARE REMOTE ALARM II |
01/30/1992 |
K832467 |
LIFECARE SERVICES, INC. |
PORTABLE LIFECARE VENTILATOR PLV-100 |
10/20/1983 |
K842876 |
LIFECARE SERVICES, INC. |
PORTABLE LIFECARE VENTILATOR PLV-102 |
08/29/1984 |
K790605 |
LIFECARE SERVICES, INC. |
RESPIRAOTR, CAM-10 RBL |
07/03/1979 |
K072926 |
LINDE GAS THERAPEUTICS |
HELONTIX VENT |
10/15/2008 |
K812642 |
LKB INSTRUMENTS, INC. |
ENGSTROM ERICA |
11/05/1981 |
K902405 |
MALLINCKRODT MEDICAL |
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR |
03/04/1991 |
K192604 |
Maquet Critica Care AB |
Servo-air 4.0 Ventilator System |
06/18/2020 |
K041223 |
MAQUET CRITICAL CARE AB |
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E |
07/29/2004 |
K123149 |
MAQUET CRITICAL CARE AB |
SERVO-I VENTILATOR SYSTEM |
06/20/2014 |
K073179 |
MAQUET CRITICAL CARE AB |
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 |
06/09/2008 |
K040221 |
MAQUET CRITICAL CARE AB |
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E |
02/20/2004 |
K062793 |
MAQUET CRITICAL CARE AB |
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION |
02/07/2007 |
K063404 |
MAQUET CRITICAL CARE AB |
SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 |
02/15/2007 |
K180098 |
Maquet Critical Care AB |
SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 |
03/19/2019 |
K151814 |
MAQUET CRITICAL CARE AB |
SERVO-U Ventilator System, SERVO-n Ventilator System |
12/21/2015 |
K860798 |
MEDIMEX, INC. |
ARF-1500 CONTINUOUS VENTILATOR |
07/10/1986 |
K871009 |
MEDIMEX, INC. |
MVP-1500 CONTINUOUS VENTILATOR |
05/06/1987 |
K925262 |
MERIT MEDICAL SYSTEMS, INC. |
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT |
01/22/1993 |
K822635 |
MONAGHAN MEDICAL CORP. |
225 S.I.M.V. VENTILATOR |
11/16/1982 |
K884389 |
MONAGHAN MEDICAL CORP. |
MODIFIED 225/SIMV VOLUME VENTILATOR |
03/12/1990 |
K790732 |
NARCO AIR-SHIELDS |
VENTIMETER CONTROLLER |
04/19/1979 |
K790733 |
NARCO AIR-SHIELDS |
VENTIMETER VENTILATOR |
04/19/1979 |
K822835 |
NARCO SCIENTIFIC |
PZ-800 VOLUME VENTILATOR |
09/29/1983 |
K070899 |
NELLCOR PURITAN BENNETT |
PURITAN BENNETT LEGENDAIR XL2 |
12/13/2007 |
K002686 |
NELLCOR PURITAN BENNETT, INC. |
ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E |
10/18/2000 |
K964543 |
NELLCOR PURITAN BENNETT, INC. |
INFRASONICS ADULT VENTILATOR TRENDING OPTION |
02/14/1997 |
K990177 |
NELLCOR PURITAN BENNETT, INC. |
NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR |
11/18/1999 |
K972248 |
NELLCOR PURITAN BENNETT, INC. |
NELLCOR PURITAN BENNETT GEMINI |
09/12/1997 |
K972833 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
E100M VENTILATOR (E100M) |
09/23/1999 |
K901785 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT "WAVE" VENTILATOR MODEL E200 |
08/10/1990 |
K121891 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT AURA VENTILATOR |
11/09/2012 |
K053502 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT E360 VENTILATOR |
01/10/2006 |
K101803 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT E360 VENTILATOR |
09/08/2010 |
K061094 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT E500 WAVE VENTILATOR |
07/28/2006 |
K030780 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT E500 WAVE VENTILATOR |
01/23/2004 |
K941309 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT ELECTRONIC MANOMETER |
03/06/1995 |
K941308 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT ELECTRONIC MANOMETER |
08/25/1995 |
K992133 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL |
08/04/2000 |
K090888 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT HT70 FAMILY OF VENTILATORS |
11/18/2009 |
K111146 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT HT70 VENTILATOR |
12/01/2011 |
K082724 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM |
12/16/2008 |
K860438 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT VENTILATOR MODEL E-100 |
05/06/1986 |
K844350 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT VENTILATOR MODEL E-100 |
12/27/1984 |
K820746 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT VENTILATOR MODEL E100 |
04/16/1982 |
K883809 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT VENTILATOR MODEL E150 |
06/23/1989 |
K181695 |
Nihon Kohden OrangeMed, Inc. |
Nihon Kohden NKV-550 Series Ventilator System |
12/07/2018 |
K192307 |
Nihon Kohden OrangeMed, Inc. |
Nihon Kohden NKV-550 Series Ventilator System |
01/10/2020 |
K002951 |
OCEANIC MEDICAL PRODUCTS, INC. |
MAGELLAN VENTILATOR |
12/08/2000 |
K772065 |
OHIO MEDICAL PRODUCTS |
CRITICAL CARE VENTILATOR 2 |
11/28/1977 |
K821376 |
OHIO MEDICAL PRODUCTS |
OHIO 7000 ELECTRONIC ANESTHESIA VENTIL. |
06/29/1982 |
K822888 |
OHIO MEDICAL PRODUCTS |
OHIO CPU-1 INTENSIVE CARE VENTILATOR |
11/16/1982 |
K830488 |
OHIO MEDICAL PRODUCTS |
VENTILATOR #1 |
09/15/1983 |
K884793 |
OHMEDA MEDICAL |
ADVENT VENTILATOR |
06/12/1989 |
K880054 |
OHMEDA MEDICAL |
CPU 1100 VENTILATOR |
04/14/1988 |
K863546 |
OHMEDA MEDICAL |
CPU GRAPH |
09/18/1986 |
K871398 |
OHMEDA MEDICAL |
CPU-1 INTENSIVE CARE VENTILATOR |
05/07/1987 |
K851509 |
OHMEDA MEDICAL |
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR |
07/15/1985 |
K864129 |
OHMEDA MEDICAL |
OHMEDA 7400 ANESTHESIA VENTILATOR |
12/16/1986 |
K883159 |
OHMEDA MEDICAL |
OHMEDA 7800 ANESTHESIA VENTILATOR |
06/06/1989 |
K902084 |
OHMEDA MEDICAL |
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE |
10/01/1990 |
K910847 |
OHMEDA MEDICAL |
OHMEDA 7810 ANESTHESIA VENTILATOR |
05/03/1991 |
K960964 |
OHMEDA MEDICAL |
OHMEDA 7900 ANESTHESIA VENTILATOR |
09/27/1996 |
K120931 |
ORICARE, INC. |
CRITICAL CARE VENTILATOR |
06/06/2013 |
K122560 |
PAN-AMERICA HYPERBARICS, INC. |
VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 |
03/26/2013 |
K051222 |
PENLON LIMITED |
AV-S ANAESTHESIA VENTILATOR |
09/23/2005 |
K010317 |
PENLON LTD. |
AV 800 VENTILATOR |
07/23/2001 |
K895486 |
PERCUSSIONAIRE CORP. |
BIRD (VDR) SINUSOIDAL PERCUSSIONATORS |
10/13/1989 |
K892886 |
PERCUSSIONAIRE CORP. |
PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR |
10/27/1989 |
K884832 |
PERCUSSIONAIRE CORP. |
PERCUSSIONAIRE RESPIRATORS (MULTIPLE) |
09/14/1989 |
K900315 |
PERCUSSIONAIRE CORP. |
PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN |
10/26/1990 |
K900314 |
PERCUSSIONAIRE CORP. |
PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN |
10/26/1990 |
K900313 |
PERCUSSIONAIRE CORP. |
PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN |
10/26/1990 |
K905234 |
PERCUSSIONAIRE CORP. |
TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES |
06/13/1991 |
K905235 |
PERCUSSIONAIRE CORP. |
VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS |
05/03/1991 |
K895513 |
PERRY BAROMEDICAL SERVICES |
PERRY SV-1 HYPERBARIC VENTILATOR |
12/19/1990 |
K820248 |
PHARMAQUEST CORP. |
RODDER VOLUME VENTILATOR |
04/16/1982 |
K832700 |
PNEU PAC, LTD. |
PNEU PAC VENTILATOR/RESUSCITATORS |
11/14/1983 |
K843737 |
PNEU PAC, LTD. |
PNEUPAC INSTANT ACTION VENTILATOR/RESUS |
10/04/1984 |
K792459 |
PNEU PAC, LTD. |
PNEUPAC VENTILATOR/RESUSCITATOR |
02/05/1980 |
K792455 |
PNEU PAC, LTD. |
PNEUPAC VENTILATOR/RESUSCITATOR #2 |
02/05/1980 |
K792456 |
PNEU PAC, LTD. |
PNEUPAC VENTILATOR/RESUSCITATOR #3 |
02/05/1980 |
K820220 |
PNEU PAC, LTD. |
VENTILATOR MODELS |
02/18/1982 |
K970158 |
PNEUPAC, INC. |
BABYPAC |
04/28/1998 |
K871433 |
PPG INDUSTRIES, INC. |
PPG BIOMEDICAL VENTILATOR MODEL AV 400 |
05/29/1987 |
K896442 |
PPG INDUSTRIES, INC. |
PPG BIOMEDICAL VENTILATOR MODEL IRISA |
04/16/1990 |
K911450 |
PREEMICARE CORP. |
INFANT VENTILATOR |
06/18/1991 |
K893622 |
PREEMICARE CORP. |
PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. |
01/03/1990 |
K092264 |
PROVIDENCE GLOBAL MEDICAL, INC. |
ATLANTIS HYPERBARIC CHAMBER VENTILATOR |
12/17/2009 |
K092263 |
PROVIDENCE GLOBAL MEDICAL, INC. |
ENDURAVENT-5 VENTILATOR |
01/21/2010 |
K060549 |
PULMONETIC SYSTEMS, INC. |
AUTOMOBILE LIGHTER POWER CORD |
05/04/2006 |
K984056 |
PULMONETIC SYSTEMS, INC. |
LTV 1000 |
04/12/1999 |
K051767 |
PULMONETIC SYSTEMS, INC. |
LTV 1000 VENTILATOR |
07/29/2005 |
K981371 |
PULMONETIC SYSTEMS, INC. |
LTV 1000 VENTILATOR |
10/30/1998 |
K060647 |
PULMONETIC SYSTEMS, INC. |
LTV 1200 VENTILATOR |
05/25/2006 |
K032226 |
PULMONETIC SYSTEMS, INC. |
LTV-1000 VENTILATOR |
10/16/2003 |
K010608 |
PULMONETIC SYSTEMS, INC. |
MODIFICATION TO LAP TOP VENTILATOR (LTV) |
03/20/2001 |
K040540 |
PULMONETIC SYSTEMS, INC. |
MODIFICATION TO LTV 1000 VENTILATOR |
04/29/2004 |
K040790 |
PULMONETIC SYSTEMS, INC. |
MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS |
06/03/2004 |
K070594 |
PULMONETIC SYSTEMS, INC. |
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 |
08/01/2007 |
K083688 |
PULMONETIC SYSTEMS, INC. |
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR |
03/18/2009 |
K002881 |
PULMONETIC SYSTEMS, INC. |
VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 |
10/11/2000 |
K862604 |
PURITAN BENNETT CORP. |
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT |
08/01/1986 |
K841757 |
PURITAN BENNETT CORP. |
7200 MICROPROCESSOR VENTILATOR |
05/16/1984 |
K854300 |
PURITAN BENNETT CORP. |
7200 MICROPROCESSOR VENTILATOR SYSTEM RESPIRATORY |
01/21/1986 |
K902506 |
PURITAN BENNETT CORP. |
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD. |
01/08/1991 |
K820393 |
PURITAN BENNETT CORP. |
ANESTHESIA VENTILATOR |
03/12/1982 |
K924043 |
PURITAN BENNETT CORP. |
AUTO-PEEP |
09/22/1994 |
K862810 |
PURITAN BENNETT CORP. |
COMPANION 2500 PORTABLE VOLUME VENTILATOR |
09/15/1986 |
K870275 |
PURITAN BENNETT CORP. |
COMPANION 2800 PORTABLE VOLUME VENTILATOR |
03/09/1987 |
K860675 |
PURITAN BENNETT CORP. |
COMPANION 2800 VOLUME VENTILATOR REMOT ALARM |
04/07/1986 |
K861488 |
PURITAN BENNETT CORP. |
COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM |
05/06/1986 |
K873215 |
PURITAN BENNETT CORP. |
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION |
01/22/1988 |
K843424 |
PURITAN BENNETT CORP. |
MICROPROCESSOR 7200A VENTILATOR |
11/01/1984 |
K833786 |
PURITAN BENNETT CORP. |
MICROPROCESSOR VENTILATOR 7200 |
12/22/1983 |
K922705 |
PURITAN BENNETT CORP. |
MODEL 7200AE VENTILATOR |
09/22/1994 |
K873151 |
PURITAN BENNETT CORP. |
MODEL 7200A, PRESSURE VENTILATION OPTION |
05/31/1988 |
K922975 |
PURITAN BENNETT CORP. |
MODEL 7200AE VENTILATOR (ENHANCEMENT) |
09/22/1994 |
K920002 |
PURITAN BENNETT CORP. |
MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50 |
11/10/1992 |
K053388 |
PURITAN BENNETT CORP. |
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION |
04/04/2006 |
K854070 |
PURITAN BENNETT CORP. |
MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM |
02/14/1986 |
K915312 |
PURITAN BENNETT CORP. |
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN |
07/08/1992 |
K964540 |
PURITAN BENNETT CORP. |
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM |
11/14/1997 |
K984379 |
PURITAN BENNETT CORP. |
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM |
12/10/1998 |
K970460 |
PURITAN BENNETT CORP. |
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) |
04/30/1998 |
K930017 |
PURITAN BENNETT CORP. |
PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD |
09/22/1994 |
K922102 |
PURITAN BENNETT CORP. |
PROPORTIONAL SOLENOID VALVE |
09/15/1994 |
K893043 |
PURITAN BENNETT CORP. |
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR |
08/04/1989 |
K001646 |
PURITAN BENNETT CORP. |
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION |
10/20/2000 |
K984535 |
PURITAN BENNETT CORP. |
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION |
12/28/1998 |
K897113 |
PURITAN BENNETT CORP. |
PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR |
03/26/1990 |
K923809 |
PURITAN BENNETT CORP. |
PURITAN-BENNETT MODEL 7200AE VENTILATOR |
10/27/1992 |
K993071 |
PURITAN BENNETT CORP. |
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 |
11/24/1999 |
K063650 |
PURITAN BENNETT CORP. |
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 |
02/15/2007 |
K823858 |
PURITAN BENNETT CORP. |
VOLUME VENTILATOR |
12/22/1982 |
K021573 |
PURITAN-BENNETT |
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION |
08/13/2002 |
K895779 |
QUINTON, INC. |
MODIFIED PERMCATH TRAY (2ND SUBMISSION) |
12/07/1989 |
K172875 |
ResMed Ltd |
Astral 100/150 |
04/26/2018 |
K151901 |
RESMED LTD. |
AirView |
11/05/2015 |
K152068 |
RESMED LTD. |
Astral 100/150 |
05/13/2016 |
K133868 |
RESMED LTD. |
ASTRAL VENTILATOR |
06/04/2014 |
K072450 |
RESPIRONICS CALIFORNIA, INC. |
ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 |
12/12/2007 |
K051262 |
RESPIRONICS CALIFORNIA, INC. |
ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 |
07/08/2005 |
K071212 |
RESPIRONICS CALIFORNIA, INC. |
ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 |
07/30/2007 |
K041412 |
RESPIRONICS CALIFORNIA, INC. |
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 |
06/18/2004 |
K023350 |
RESPIRONICS CALIFORNIA, INC. |
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS |
11/06/2002 |
K110795 |
RESPIRONICS CALIFORNIA, INC. |
V200 INTELLI-TRAK OPTION |
08/19/2011 |
K102054 |
RESPIRONICS CALIFORNIA, INC. |
V200 VENTILATOR |
12/22/2010 |
K110083 |
RESPIRONICS CALIFORNIA, INC. |
V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE |
01/13/2012 |
K181166 |
Respironics Inc. |
Trilogy Evo |
07/18/2019 |
K181170 |
Respironics Inc. |
Trilogy Evo Universal |
07/18/2019 |
K072588 |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
PERFORMAX SE TOTAL FACE MASK |
12/18/2007 |
K092648 |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
RESPIRONICS PERFORMAX SE TOTAL FACE MASK |
12/18/2009 |
K083526 |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
TRILOGY 100 VENTILATOR |
03/13/2009 |
K150638 |
Respironics, Inc. |
AF541 SE Full Face Mask |
09/18/2015 |
K001208 |
RESPIRONICS, INC. |
ESPIRT |
05/12/2000 |
K981072 |
RESPIRONICS, INC. |
ESPRIT VENTILATOR |
11/12/1998 |
K101129 |
RESPIRONICS, INC. |
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK |
09/16/2010 |
K034040 |
RESPIRONICS, INC. |
ESPRIT VENTILATOR, MODEL V1000 |
01/21/2004 |
K921726 |
RESPIRONICS, INC. |
HAYEK OSCILLATOR, MODIFICATION |
04/23/1992 |
K023135 |
RESPIRONICS, INC. |
IMAGE3 SE DISPOSABLE FULL FACE MASK |
01/03/2003 |
K120639 |
RESPIRONICS, INC. |
PERFORMAX PEDIATRIC SE TOTAL FACE MASK |
07/10/2012 |
K093416 |
RESPIRONICS, INC. |
TRILOGY 200 VENTILATOR |
01/29/2010 |
K093905 |
RESPIRONICS, INC. |
TRILOGY 202 VENTILATOR |
05/12/2010 |
K111610 |
RESPIRONICS, INC. |
TRILOGY SERIES VENTILATOR WITH OXIMETRY |
10/14/2011 |
K782074 |
RULE MEDICAL INSTRUMENTS, INC. |
VENTILATOR, MODEL AVA-1, ADULT |
12/21/1978 |
K896735 |
S & W MEDICO TEKNIK |
TYPE 9290 INTERFACE RESPIRATOR |
02/28/1990 |
K896736 |
S & W MEDICO TEKNIK |
TYPE 9291 INTERFACE RESPIRATOR |
02/28/1990 |
K922314 |
S & W MEDICO TEKNIK |
VENTILATOR INTERFACE 9291/4 |
12/17/1992 |
K920121 |
SECHRIST |
SECHRIST IV-100B SAVI SYSTEM |
02/01/1993 |
K780188 |
SECHRIST INDUSTRIES, INC. |
INFANT VENTILATOR MODEL 100 |
04/10/1978 |
K993167 |
SECHRIST INDUSTRIES, INC. |
MILLENNIUM INFANT VENTILATOR |
11/10/1999 |
K833982 |
SECHRIST INDUSTRIES, INC. |
MODEL IV 100B-DA INFANT VENTILATOR |
03/05/1984 |
K811141 |
SECHRIST INDUSTRIES, INC. |
SECHRIST INFANT VENTRILATOR MODEL IV-100 |
06/12/1981 |
K821930 |
SECHRIST INDUSTRIES, INC. |
SECHRIST MODEL 990 JET VENTILATOR |
08/16/1982 |
K896269 |
SECHRIST INDUSTRIES, INC. |
SECHRIST VOLUME VENTILATOR MODEL 2200B |
05/18/1990 |
K914607 |
SECHRIST INDUSTRIES, INC. |
SEHRIST VOLUME VENTILATOR, MODEL 2200B |
11/02/1992 |
K832508 |
SECHRIST INDUSTRIES, INC. |
VOLUME VENTILATOR |
12/27/1983 |
K841393 |
SIEMENS ELEMA AB |
AB MANUAL VENTILATION ACCESS. 900C |
05/21/1984 |
K850374 |
SIEMENS ELEMA AB |
CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO |
04/25/1985 |
K864105 |
SIEMENS ELEMA AB |
LUNG MECHANICS SOFTWARE PROGRAM |
11/07/1986 |
K861707 |
SIEMENS ELEMA AB |
MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR |
06/19/1986 |
K852771 |
SIEMENS ELEMA AB |
PC INTERFACE |
10/10/1985 |
K844590 |
SIEMENS ELEMA AB |
POWER PACK 160 SIEMENS-ELEMA AB |
11/29/1984 |
K960010 |
SIEMENS ELEMA AB |
SERVO VENTILATOR 300 COMPUTER INTERFACE |
10/25/1996 |
K970839 |
SIEMENS ELEMA AB |
SERVO VENTILATOR 300A |
10/14/1997 |
K871354 |
SIEMENS ELEMA AB |
SERVO VENTILATOR 900 C/D |
07/21/1987 |
K844912 |
SIEMENS ELEMA AB |
SERVO VENTILATOR 900D SIEMENS-ELEMA AB |
12/28/1984 |
K010925 |
SIEMENS ELEMA AB |
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E |
12/18/2001 |
K960168 |
SIEMENS ELEMA AB |
SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 |
10/25/1996 |
K800114 |
SIEMENS ELEMA AB |
SIEMENS-ELEMA AB MANUAL VENTILATION |
03/05/1980 |
K811102 |
SIEMENS ELEMA AB |
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C |
05/05/1981 |
K841529 |
SIEMENS ELEMA AB |
SIEMENS-ELEMA VENTILATOR 900C |
05/23/1984 |
K890921 |
SIEMENS LIFE SUPPORT SYSTEMS |
DATA EXCHANGE SYSTEM, MODEL 24 |
06/08/1989 |
K893786 |
SIEMENS LIFE SUPPORT SYSTEMS |
SERVO ANESTHESIA CIRCLE 985 |
09/22/1989 |
K902859 |
SIEMENS LIFE SUPPORT SYSTEMS |
SERVO VENTILATOR 300 |
04/26/1991 |
K923992 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
POWER PACK 350/BATTERY PACK 351 |
04/13/1993 |
K923444 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SERVO GRAPHICS |
03/05/1993 |
K022132 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E |
09/19/2002 |
K884520 |
SIEMENS-ELEMA VENTILATION SYSTEMS |
SERVO VENTILATOR 900E |
01/17/1989 |
K190533 |
Sleepnet Corporation |
Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented |
07/26/2019 |
K063806 |
SLEEPNET CORPORATION |
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED |
05/17/2007 |
K112729 |
SPACELABS HEALTHCARE |
BLEASE700/900 SERIES VENTILATORS |
06/11/2012 |
K113051 |
SPACELABS HEALTHCARE |
SPACELABS ARKON ANESTHESIA WORKSTATION |
03/22/2012 |
K101850 |
SPACELABS HEALTHCARE LTD. |
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION |
03/02/2011 |
K872113 |
STEIN-GATES MEDICAL EQUIPMENT, INC. |
OMNI-VENT, SERIES D |
03/23/1988 |
K881420 |
STEIN-GATES MEDICAL EQUIPMENT, INC. |
OMNI-VENT, SERIES D/MRI |
06/14/1988 |
K111595 |
TECME S.A. |
NEUMOVENT GRAPHNET |
01/27/2012 |
K101401 |
TECME S.A. |
NEUMOVENT GRAPHNET MODEL 3179L1V |
12/07/2010 |
K822103 |
THOMPSON RESPIRATION PRODUCTS, INC. |
MODEL M3000XA VENTILATOR SPECIFICA |
07/26/1982 |
K781161 |
THOMPSON RESPIRATION PRODUCTS, INC. |
RESPIRATOR, BANTAM MODEL |
12/11/1978 |
K781160 |
THOMPSON RESPIRATION PRODUCTS, INC. |
VENTILATOR, MINILUNG |
12/13/1978 |
K781159 |
THOMPSON RESPIRATION PRODUCTS, INC. |
VENTILATOR, PRESSURE |
12/12/1978 |
K821792 |
ULTRAMAR MARKETING CORP. |
NEUMOVENT 980 |
08/02/1982 |
K162877 |
VENTEC LIFE SYSTEMS, INC |
VOCSN Unified Respiratory System |
04/07/2017 |
K011957 |
VERSAMED LTD. |
IVENT 201 PORTABLE VENTILATOR |
07/18/2001 |
K981668 |
VERSAMED LTD. |
SMARTVENT 201 PORTABLE VENTILATOR |
04/07/1999 |
K112754 |
VERSAMED MEDICAL SYSTEMS LTD. |
IVENT101 |
06/15/2012 |
K092135 |
VERSAMED MEDICAL SYSTEMS LTD. |
MODIFICATION TO IVENT 101 |
11/23/2009 |
K073694 |
VERSAMED MEDICAL SYSTEMS, INC. |
IVENT 2001 MRI CONDITIONAL |
05/30/2008 |
K053270 |
VERSAMED MEDICAL SYSTEMS, INC. |
IVENT 201 |
01/27/2006 |
K042468 |
VERSAMED MEDICAL SYSTEMS, INC. |
IVENT 201 PORTABLE VENTILATOR |
11/17/2004 |
K081845 |
VERSAMED MEDICAL SYSTEMS, INC. |
IVENT101 |
03/16/2009 |
K061627 |
VERSAMED MEDICAL SYSTEMS, INC. |
MODIFICATION TO I VENT 201 |
06/29/2006 |
K052554 |
VERSAMED MEDICAL SYSTEMS, INC. |
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR |
09/23/2005 |
K062093 |
VIASYS RESPIRATORY CARE INC |
AVEA VENTILATOR |
09/20/2006 |
K073069 |
VIASYS RESPIRATORY CARE INC |
MODIFICATION TO AVEA VENTILATOR |
01/25/2008 |
K791713 |
VICKERS AMERICA MEDICAL CORP. |
VICKERS MEDICAL MODEL 130 NEAVENT-NEO |
09/19/1979 |
K831877 |
W.E. LEDER ENTERPRISES, INC. |
ARF 850 E |
11/03/1983 |
K162832 |
ZOLL MEDICAL CORPORATION |
731 Series Ventilators |
08/02/2017 |