FDA 510(k) Applications for Medical Device Product Code "BTL"
(Ventilator, Emergency, Powered (Resuscitator))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K080692 | AIRON CORPORATION | MACS CPAP SYSTEM | 06/20/2008 |
| K132021 | ALLIED HEALTHCARE PRODUCTS, INC. | AHP 300, EMERGENCY PORTABLE VENTILATOR | 04/02/2014 |
| K070636 | ALLIED HEALTHCARE PRODUCTS, INC. | AUTOVENT 4000 WITH CPAP | 07/13/2007 |
| K070120 | ALLIED HEALTHCARE PRODUCTS, INC. | AUTOVENT MODEL 4000 | 05/03/2007 |
| K083507 | ALLIED HEALTHCARE PRODUCTS, INC. | BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS | 05/18/2009 |
| K131098 | ALLIED HEALTHCARE PRODUCTS, INC. | EMERGENCY PORTABLE VENTILATOR | 04/09/2014 |
| K090356 | ALLIED HEALTHCARE PRODUCTS, INC. | EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 | 05/20/2009 |
| K080063 | ALLIED HEALTHCARE PRODUCTS, INC. | MASS CASUALTY VENTILATOR, MODEL MCV100 | 08/15/2008 |
| K083385 | ALLIED HEALTHCARE PRODUCTS, INC. | MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B | 05/14/2009 |
| K072214 | ALLIED HEALTHCARE PRODUCTS, INC. | PORTABLE VENTILATOR, MODEL EPV-100 | 03/06/2008 |
| K904920 | AMBU, INC. | AMBU MATIC AUTOMATIC RESUSCITATOR | 05/28/1991 |
| K921926 | ANESTHESIA ASSOC., INC. | JET VENTILATOR/JETTING DEVICE | 10/13/1992 |
| K102542 | ATOM MEDICAL CORPORATION | RESUSCI FLOW; RESUSCI FLOW 104 | 04/06/2011 |
| K131877 | AUTOMEDX INC. | SAVE II, SAVE II BASIC | 03/21/2014 |
| K071221 | AUTOMEDX INC. | SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 | 09/06/2007 |
| K895946 | BIVONA MEDICAL TECHNOLOGIES | BIVONA CARDEN INTERMITTENT JETTING DEVICE | 01/09/1990 |
| K944349 | CPR MEDICAL DEVICES, INC. | OXYLATOR EM-100 | 04/17/1995 |
| K841893 | CRYO2 CORP. | MAXAMAN | 08/30/1984 |
| K132759 | DOLPHYS MEDICAL B.V. | VENTRAIN | 03/26/2014 |
| K951126 | DRAGER, INC. | DRAGER MEDICAL AIR COMPRESSOR | 03/24/1995 |
| K021520 | EMERGENCY MEDICAL TECHOLOGY | EMT-CPAP | 07/15/2002 |
| K892885 | FISHER & PAYKEL ELECTRONICS LTD. | RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR | 10/06/1989 |
| K771299 | FRASER SWEATMAN, INC. | EMERGENCY OXYGEN RESUSCITATOR | 08/04/1977 |
| K882833 | HURSCH ENT., INC. | THE BERG RESUSCITATION APPARATUS | 08/19/1988 |
| K931473 | IMPACT INSTRUMENTATION, INC. | IMPACT MODEL 753 | 12/30/1994 |
| K861272 | IMPACT INSTRUMENTATION, INC. | IMPACT MODELS 701, 702 AND 703 | 05/20/1986 |
| K905697 | IMPACT INSTRUMENTATION, INC. | POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE | 12/27/1990 |
| K032386 | IMPACT INSTRUMENTATION, INC. | UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) | 03/26/2004 |
| K051476 | IMPACT INSTRUMENTATION, INC. | UNI-VENT MODEL 73X | 10/28/2005 |
| K991785 | INSTRUMENTATION INDUSTRIES, INC. | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR | 08/17/1999 |
| K860077 | INSTRUMENTATION INDUSTRIES, INC. | SG-066 OXYGEN ENRICHMENT KIT | 02/18/1986 |
| K140707 | INTERNATIONAL BIOMEDICAL | LIFEBORNE INFANT RESUSCITATOR | 05/28/2014 |
| K182956 | International Biomedical | Puffin Lite Infant Resuscitation System | 01/18/2019 |
| K920910 | J. H. EMERSON CO. | OXYGEN POWERED RESUSCITATOR FOR CPR | 01/12/1993 |
| K800456 | KHI, INC. | EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR. | 03/18/1980 |
| K830404 | KHI, INC. | RAD VALVE | 03/17/1983 |
| K855092 | LIFE CORP. | LIFE CORP. OXYGEN PAC | 01/21/1986 |
| K910201 | LIFE CORP. | LIFE O2 | 02/01/1991 |
| K910435 | LIFE CORP. | LIFE OXYGENPAC 6/12 LPM | 06/17/1991 |
| K910434 | LIFE CORP. | LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL | 06/17/1991 |
| K910699 | LIFE CORP. | LIFE-02 (NON-REFILLABLE CYLINDER) | 06/18/1991 |
| K851337 | LIFE SUPPORT PRODUCTS, INC. | 502 RESUSCITATORY INHALATOR VALVE | 05/15/1985 |
| K874656 | LIFE SUPPORT PRODUCTS, INC. | AUTOMATIC VENTILATOR AV2000 | 01/19/1988 |
| K870424 | LIFE SUPPORT PRODUCTS, INC. | LSP AUTOMATIC VENTILATOR, MODEL 456 | 01/22/1988 |
| K932200 | LIFE SUPPORT PRODUCTS, INC. | LSPI AUTOMATIC VENTILATOR | 11/24/1993 |
| K941870 | LIFE SUPPORT PRODUCTS, INC. | LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 | 01/09/1995 |
| K932199 | LIFE SUPPORT PRODUCTS, INC. | LSPI AUTOMATIC VENTILATOR, MODEL AV3000 | 11/24/1993 |
| K941871 | LIFE SUPPORT PRODUCTS, INC. | LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 | 01/09/1995 |
| K915564 | LIFE SUPPORT PRODUCTS, INC. | SPIROS | 01/30/1992 |
| K924272 | MEDFLOW CORP., INC. | MEDIRESP III | 02/09/1994 |
| K142096 | MERCURY MEDICAL | T-PIECE RESUSCITATOR | 10/17/2014 |
| K093913 | MERCURY MEDICAL, INC. | MERCURY MEDICAL T-PIECE RESUSCITATOR | 04/06/2010 |
| K092085 | NEOFORCE GROUP, INC. | ISPIRA RESUSCITATION UNIT | 10/07/2009 |
| K884089 | NEOTRONICS MEDICAL LTD. | ERA 2000 EMERGENCY RESUSCITATOR | 12/20/1988 |
| K911261 | NEOTRONICS, INC. | ERA 2000A | 05/31/1991 |
| K051469 | O-TWO MEDICAL TECHNOLOGIES, INC. | CAREVENT ATV+ AND CAREVENT MRI | 09/28/2005 |
| K051889 | O-TWO MEDICAL TECHNOLOGIES, INC. | CAREVENT CA AND DRA | 08/30/2005 |
| K093862 | O-TWO MEDICAL TECHNOLOGIES, INC. | CAREVENT HANDHELD CPAP SYSTEM | 05/06/2010 |
| K081330 | O-TWO MEDICAL TECHNOLOGIES, INC. | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | 03/06/2009 |
| K141595 | O-TWO MEDICAL TECHNOLOGIES, INC. | O-TWO E700,O-TWO E600,O-TWO E500 | 03/16/2015 |
| K983785 | O-TWO SYSTEMS INTL., INC. | AUTOVENT 1000 | 10/29/1998 |
| K983857 | O-TWO SYSTEMS INTL., INC. | AUTOVENT 1500 | 11/04/1998 |
| K991195 | O-TWO SYSTEMS INTL., INC. | CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV | 04/22/1999 |
| K983705 | O-TWO SYSTEMS INTL., INC. | EMT RESUSCITATOR | 10/29/1998 |
| K913039 | O-TWO SYSTEMS INTL., INC. | FLLYNN(R) GENESIS AC | 08/25/1992 |
| K932170 | O-TWO SYSTEMS INTL., INC. | FLYNNR GENESIS II A/C, A/O AND IDLH | 10/25/1993 |
| K983643 | O-TWO SYSTEMS INTL., INC. | GENESIS BLS | 10/29/1998 |
| K070210 | OHMEDA MEDICAL | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | 04/20/2007 |
| K901846 | OHMEDA MEDICAL | OHMEDA - LOGIC 07A TRANSPORT VENTILATOR | 08/08/1990 |
| K021841 | PNEU PAC, LTD. | COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER | 07/17/2003 |
| K862830 | PNEU PAC, LTD. | MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR | 10/15/1986 |
| K960515 | PNEU PAC, LTD. | PARAPAC | 10/10/1996 |
| K020899 | PNEU PAC, LTD. | PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D | 12/13/2002 |
| K030803 | PNEU PAC, LTD. | PARAPAC 200D TRANSPORT, MODEL V200D | 09/29/2003 |
| K863410 | PNEU PAC, LTD. | PATIENT VALVE WITH AIR ENTRAINMENT | 01/12/1987 |
| K792453 | PNEU PAC, LTD. | PNEUPAC OXYGEN THERAPY UNIT | 02/05/1980 |
| K040090 | PNEUPAC LTD. | COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) | 05/27/2004 |
| K780168 | POHLMANN RESCUE PRODUCTS, INC. | PARAMEDIC O2 KIT | 04/18/1978 |
| K944397 | RACAL HEALTH & SAFETY, INC. | BNOS MICROVENT, MODEL AC AND MODEL AO | 01/31/1995 |
| K123957 | SMITHS MEDICAL INTERNATIONAL LTD. | PNEUPAC PARAPAC PLUS | 09/16/2013 |
| K043495 | SMITHS MEDICAL INTERNATIONAL LTD., LUTON | BABYPAC | 04/22/2005 |
| K071527 | SMITHS MEDICAL INTERNATIONAL, LTD. | PNEUPAC VR1 AIR MIX | 10/04/2007 |
| K051322 | SMITHS MEDICAL INTERNATIONAL, LTD. | PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS | 08/05/2005 |
| K982225 | SPIRACLE TECHNOLOGY | SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 | 10/28/1998 |
| K853971 | STEPHENSON INDUSTRIES, INC. | REGULATOR-INHALATOR SYSTEM | 12/09/1985 |
| K093261 | THORNHILL RESEARCH INC | MOVES | 03/26/2010 |
| K140049 | THORNHILL RESEARCH INC | MOVES SLC | 05/29/2014 |
| K161420 | THORNHILL RESEARCH INC. | MOVES SLC | 06/06/2017 |
| K862192 | U.O. EQUIPMENT CO. | RESUSCITATOR MODELS 10400/10500/10600/10700/10800 | 07/07/1986 |
| K112783 | VBM MEDIZINTECHNIK GMBH | MANUJET III | 12/22/2011 |
| K173373 | Ventlab, LLC | SafeT T-Piece Resuscitator | 11/16/2018 |
| K001430 | VORTRAN MEDICAL TECHNOLOGY 1, INC. | RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 | 07/05/2000 |
| K973975 | VORTRAN MEDICAL TECHNOLOGY 1, INC. | RESPIRTECHPRO | 06/12/1998 |
| K073261 | VORTRAN MEDICAL TECHNOLOGY 1, INC. | VAR MONITOR | 05/23/2008 |
| K041473 | VORTRAN MEDICAL TECHNOLOGY 1, INC. | VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM | 07/15/2004 |
| K162968 | VORTRAN MEDICAL TECHNOLOGY 1, INC. | VORTRAN GO2VENT | 04/10/2017 |
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