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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K881482 | HAMILTON MEDICAL, INC. | VEOLAR VENTILATOR | 06/16/1988 |
| K901448 | HAMILTON MEDICAL, INC. | VEOLAR VENTILATOR | 12/20/1991 |
| K871792 | HAMILTON MEDICAL, INC. | VEOLAR VENTILATOR | 04/21/1988 |
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| K162832 | ZOLL MEDICAL CORPORATION | 731 Series Ventilators | 08/02/2017 |
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