FDA 510(k) Applications for Medical Device Product Code "CBK"
(Ventilator, Continuous, Facility Use)

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
K020746 BIRD PRODUCTS CORP. BIRD TBIRD VELA VENTILATOR 04/22/2002
K032451 BIRD PRODUCTS CORP. BIRD TBIRD VELA VENTILATOR 03/17/2004
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
K982174 CARDIOPULMONARY CORP. VENTURI VENTILATOR 06/24/1998
K943412 CARDIOPULMONARY CORP. VENTURI VENTILATOR 10/16/1995
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
K050597 DATEX-OHMEDA, INC. GE DATEX-OHMEDA ENGSTROM CARESTATION 03/25/2005
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
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
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
K130171 FLIGHT MEDICAL INNOVATIONS LTD. FLIGHT 60 VENTILATOR 04/08/2014
K111683 FLIGHT MEDICAL INNOVATIONS LTD. FLIGHT 60 VENTILATOR 10/31/2011
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
K092148 HAMILTON MEDICAL AG HAMILTON-C2 03/04/2010
K121225 HAMILTON MEDICAL AG HAMILTON-C2 11/16/2012
K102775 HAMILTON MEDICAL AG HAMILTON-C2 01/21/2011
K090468 HAMILTON MEDICAL AG HAMILTON-C2 06/15/2009
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
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
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
K871792 HAMILTON MEDICAL, INC. VEOLAR VENTILATOR 04/21/1988
K861432 HAMILTON MEDICAL, INC. VEOLAR VENTILATOR 05/06/1986
K881482 HAMILTON MEDICAL, INC. VEOLAR VENTILATOR 06/16/1988
K901448 HAMILTON MEDICAL, INC. VEOLAR VENTILATOR 12/20/1991
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
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
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
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
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K172875 ResMed Ltd Astral 100/150 04/26/2018
K151901 RESMED LTD. AirView 11/05/2015
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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
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