FDA 510(k) Applications for Medical Device Product Code "CBK"
(Ventilator, Continuous, Facility Use)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| 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 |
| K952880 | AEQUITRON MEDICAL, INC. | MODEL LP-1000 VOLUME VENTILATOR | 06/20/1996 |
| 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 |
| K992788 | BEAR MEDICAL SYSTEMS, INC. | BEAR CUB 750 PSV | 09/16/1999 |
| K173973 | Bio-Med Devices, Inc. | TV-100 | 07/20/2018 |
| K013642 | BIRD PRODUCTS CORP. | AVEA | 05/22/2002 |
| K022674 | BIRD PRODUCTS CORP. | BIRD AVEA VENTILATOR | 11/06/2002 |
| K982580 | BIRD PRODUCTS CORP. | BIRD MONITOR INTERFACE | 10/22/1998 |
| 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 |
| 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 |
| K982132 | BLEASE MEDICAL EQUIPMENT LTD. | BLEASE 6200 ANAESTHESIA VENTILATOR | 04/15/1999 |
| K141943 | BREATHE TECHNOLOGIES | BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM | 06/12/2015 |
| K170037 | Breathe Technologies | Breathe Technologies Life2000Ö Ventilation System | 08/11/2017 |
| 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 |
| 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 |
| K241135 | CorVent Medical, Inc. | RESPOND(R) Ventilator | 11/13/2024 |
| 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 |
| K193056 | Covidien, LLC | Puritan Bennett 980 Series Ventilator System | 11/20/2020 |
| 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 |
| K210384 | Datex-Ohmeda, Inc. | CARESCAPE R860 | 11/04/2021 |
| 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 |
| K041775 | DATEX-OHMEDA, INC. | GE DATEX-OHMEDA ENGSTROM CARESTATION | 10/26/2004 |
| 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 |
| K041524 | DATEX-OHMEDA, INC. | GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM | 09/20/2004 |
| K232836 | Dimar S.p.A | Family of DIMAR DMAX NIV masks | 08/14/2024 |
| 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 |
| 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 |
| K980208 | DRAEGER MEDICAL, INC. | DIVAN ANESTHESIA VENTILATOR | 08/04/1998 |
| K953228 | DRAEGER MEDICAL, INC. | NARKOMED AV2+ ANESTHESIA VENTILATOR | 03/01/1996 |
| K222207 | Draegerwerk AG & CO KGaA | Babylog VN800, Babylog VN600 | 05/16/2023 |
| K222024 | Draegerwerk AG & Co. KGaA | Evita V800, Evita V600 | 05/16/2023 |
| K093633 | Draegerwerk AG & Co. KGaA | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE | 03/30/2010 |
| 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 |
| 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 |
| 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 |
| K180779 | Dragerwerk AG & CO. KGaA | Savina 300 | 01/17/2019 |
| 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 |
| K203449 | Fisher & Paykel Healthcare Ltd | F&P Visairo NIV Mask Range | 04/14/2021 |
| 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 |
| K111683 | FLIGHT MEDICAL INNOVATIONS LTD. | FLIGHT 60 VENTILATOR | 10/31/2011 |
| K120726 | FLIGHT MEDICAL INNOVATIONS LTD. | FLIGHT 60 VENTILATOR | 07/06/2012 |
| K130171 | FLIGHT MEDICAL INNOVATIONS LTD. | FLIGHT 60 VENTILATOR | 04/08/2014 |
| K223120 | Flight Medical Innovations Ltd. | Ventoux VC2; Ventoux VC3 | 12/02/2024 |
| K100753 | FLIGHT MEDICAL LTD. | FLIGHT 60 VENTILATOR, MODEL F-60 | 08/20/2010 |
| K061090 | HAMILTON MEDICAL AG | GALILEO GOLD ASV | 07/17/2006 |
| K120574 | HAMILTON MEDICAL AG | HAMILTON-C1 | 05/30/2012 |
| K090468 | HAMILTON MEDICAL AG | HAMILTON-C2 | 06/15/2009 |
| K092148 | HAMILTON MEDICAL AG | HAMILTON-C2 | 03/04/2010 |
| K102775 | HAMILTON MEDICAL AG | HAMILTON-C2 | 01/21/2011 |
| K121225 | HAMILTON MEDICAL AG | HAMILTON-C2 | 11/16/2012 |
| K161450 | HAMILTON MEDICAL AG | HAMILTON-C3 | 04/27/2017 |
| K201306 | Hamilton Medical AG | HAMILTON-C3 | 02/05/2021 |
| K123637 | HAMILTON MEDICAL AG | HAMILTON-C3 | 12/21/2012 |
| K201658 | Hamilton Medical AG | Hamilton-C6 | 12/11/2020 |
| K070513 | HAMILTON MEDICAL AG | HAMILTON-G5 | 11/26/2007 |
| K103803 | HAMILTON MEDICAL AG | HAMILTON-G5 | 11/23/2011 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K062019 | INNOMED TECHNOLOGIES INC./RESPCARE INC. | RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD | 08/17/2006 |
| K202970 | Inovytech Medical Solutions Ltd. | Ventway Sparrow | 01/29/2021 |
| K992670 | INSTRUMENTATION INDUSTRIES, INC. | OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 | 09/17/1999 |
| K082351 | LEVEL-5, INC. | NEPTUNE HYPERBARIC VENTILATOR | 01/02/2009 |
| K072926 | LINDE GAS THERAPEUTICS | HELONTIX VENT | 10/15/2008 |
| 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 |
| K201874 | Maquet Critical Care AB | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 | 04/20/2021 |
| 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 |
| 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 |
| 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 |
| 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 |
| K222644 | Nihon Kohden OrangeMed, Inc. | Nihon Kohden NKV-440 Ventilator System | 05/31/2023 |
| 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 |
| K231778 | Nihon Kohden OrangeMed, LLC | Nihon Kohden NKV-550 Series Ventilator System | 03/01/2024 |
| K002951 | OCEANIC MEDICAL PRODUCTS, INC. | MAGELLAN VENTILATOR | 12/08/2000 |
| K960964 | OHMEDA MEDICAL | OHMEDA 7900 ANESTHESIA VENTILATOR | 09/27/1996 |
| K120931 | ORICARE, INC. | CRITICAL CARE VENTILATOR | 06/06/2013 |
| K213098 | Origin Medical Devices | Panther 5 | 07/20/2023 |
| 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 |
| K970158 | PNEUPAC, INC. | BABYPAC | 04/28/1998 |
| 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 |
| K053388 | PURITAN BENNETT CORP. | MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION | 04/04/2006 |
| 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 |
| 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 |
| 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 |
| K021573 | PURITAN-BENNETT | PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION | 08/13/2002 |
| 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 |
| K243394 | Respironics Inc. | AF531 Oro-Nasal SE Face Mask | 12/30/2024 |
| 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 |
| 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 |
| K993167 | SECHRIST INDUSTRIES, INC. | MILLENNIUM INFANT VENTILATOR | 11/10/1999 |
| K220107 | Shenzhen Mindray Bio-medical Electronics Co.,LTD. | Mindray SV600 Ventilator, Mindray SV800 Ventilator | 06/16/2023 |
| K960010 | SIEMENS ELEMA AB | SERVO VENTILATOR 300 COMPUTER INTERFACE | 10/25/1996 |
| K970839 | SIEMENS ELEMA AB | SERVO VENTILATOR 300A | 10/14/1997 |
| 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 |
| K022132 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E | 09/19/2002 |
| 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 |
| K241520 | Sleepnet Corporation | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | 06/27/2024 |
| K241943 | Sleepnet Corporation | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | 08/28/2024 |
| 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 |
| K111595 | TECME S.A. | NEUMOVENT GRAPHNET | 01/27/2012 |
| K101401 | TECME S.A. | NEUMOVENT GRAPHNET MODEL 3179L1V | 12/07/2010 |
| K251133 | Telesair Inc. | AVEA disposable expiratory filter/water trap (11790) | 05/08/2025 |
| K162877 | VENTEC LIFE SYSTEMS, INC | VOCSN Unified Respiratory System | 04/07/2017 |
| K240807 | Ventis Medical, Inc. | VM-2000 | 08/13/2024 |
| 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 |
| K201082 | Vyaire Medical Inc | LTV2 Series Ventilators | 11/10/2021 |
| K233486 | Zoll Medical Corporation | 731 Series Ventilator | 12/13/2024 |
| K162832 | ZOLL MEDICAL CORPORATION | 731 Series Ventilators | 08/02/2017 |
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