FDA 510(k) Applications for Medical Device Product Code "BTI"
(Compressor, Air, Portable)

FDA 510(k) Number Applicant Device Name Decision Date
K951926 ALLAN REHNSTROM AB ALRECO 40400 12/08/1995
K853944 AMERICAN AIR & PROCESS, INC. CPAP BLOWER 11/21/1985
K852622 ASHAI CO. LTD. AEROSOL ONE 04/24/1986
K870428 ASHAI CO. LTD. AEROSOL ONE, NEBULIZER PUMP 05/15/1987
K844956 AVATRON, INC. AVA-MIST PORTABLE AIR COMPRESSOR 02/14/1985
K850795 BEAR MEDICAL SYSTEMS, INC. AIR COMPRESSOR 05/28/1985
K883704 BIOTRINE CORP. MULTIICHALLENGE NEBULIZER SYSTEM 11/28/1988
K864547 BIRD PRODUCTS CORP. BIRD 6500 AIR COMPRESSOR 01/12/1987
K822685 CERTIFIED RESPIRATORY SERVICES, INC. NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY 09/21/1982
K963349 DEVILBISS HEALTH CARE, INC. DEVILBISS 8650D 06/13/1997
K931015 DEVILBISS HEALTH CARE, INC. DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER 09/30/1993
K902520 DIAMOND MEDICAL EQUIPMENT, INC. AIR PLUS NEBULIZER 03/04/1991
K982789 DRAGER, INC. MEDICAL AIR COMPRESSOR, MODEL # 8413419 10/29/1998
K801286 E.B.E. RESEARCH & MFG., INC. PORTA-NEB(R) 310 07/08/1980
K091871 EKOM S.R.O. DK50 DS 10/23/2009
K060781 EKOM S.R.O. MEDICAL COMPRESSOR, MODELS DK50 D AND DM 10/03/2006
K072634 EMG TECHNOLOGY CO., LTD. EMG TRITON -COMP,MODEL NCA01-XXX SERIES 11/19/2008
K894831 EQUI-TRON MFG., INC. PORTABLE AIR COMPRESSOR MODEL NUMBER 8125 10/24/1989
K861865 ERIE MEDICAL ERIE-NEB 07/01/1986
K040220 EVENT MEDICAL LTD MEDICAL AIR COMPRESSOR 06/09/2004
K913097 FERGUSON MEDICAL SAM ST 12/11/1992
K800534 GREENE & KELLOGG, INC. MODEL 52 BUNN DRY AIR SUPPLY 03/25/1980
K041781 HAMILTON MEDICAL AG VENTILAIR II MEDICAL AIR COMPRESSOR 03/14/2005
K761294 HARRIS-LAKE, INC. RESPIRATORY BLOWER 01/03/1977
K922623 HEALTHDYNE, INC. NEBULIZER SYSTEM 12/01/1992
K802253 HUDSON OXYGEN THERAPY SALES CO. AIR COMPRESSOR ADAPTOR KIT 09/26/1980
K841537 IMPACT INSTRUMENTATION, INC. IMPACT MODEL 601 05/31/1984
K920954 INFRASONICS CORP. AIR STAR 08/03/1992
K946039 INTERNATIONAL MEDICAL SYSTEMS MODEL #5000 "PULMO PLUS" 06/16/1995
K820079 JAMES L. GERACI & ASSOCIATES, INC. AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL 02/05/1982
K884722 LUMISCOPE CO., INC. LUMINEB I 02/03/1989
K041974 MED2000 S.R.L. MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER 08/24/2004
K904045 MEDICAL INDUSTRIES AMERICA, INC. #504 MINI COMPRESSOR 02/12/1991
K940630 MEDICAL INDUSTRIES AMERICA, INC. 503 MAXI COMPRESSOR 02/21/1995
K902184 MEDICAL INDUSTRIES AMERICA, INC. MAXI ASPIRATOR 02/12/1991
K900686 MEDICAL INDUSTRIES AMERICA, INC. MAXI COMPRESSORS 04/26/1990
K832220 MEDIX OF FLORIDA, INC. TRAVELER NEBULIZING SYSTEM 09/26/1983
K031686 MEDLINE INDUSTRIES, INC. AEROMIST LT, MODEL HCS15004 01/21/2004
K873677 MOUNTAIN MEDICAL EQUIPMENT, INC. ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER 10/20/1987
K833501 MOUNTAIN MEDICAL EQUIPMENT, INC. MEDI-MIST PORTA. COMPRESSOR DRIVEN 12/12/1983
K883829 NECON MEDICAL, INC. TURBO AIR COMPRESSOR 8000 03/23/1989
K041406 NEWPORT MEDICAL INSTRUMENTS NEWPORT C250 AIR COMPRESSOR MODEL C250 12/15/2004
K020797 NIDEK MEDICAL PRODUCTS, INC. PULMO-MIST COMPRESSOR MODEL # 4323 05/03/2002
K854306 OHMEDA MEDICAL OHMEDA CPU AIR COMPRESSOR MODEL 3350 11/01/1985
K113338 ORICARE, INC. MEDICAL AIR COMPRESSOR 08/10/2012
K002862 PARI HOLDING CO. PRONEB ULTRA MODEL NUMBER 85B0100 03/13/2001
K792457 PNEU PAC, LTD. COMPRESSOR 02/05/1980
K051691 PRECISION MEDICAL, INC. MINIMATE COMPRESSOR 12/09/2005
K930509 PRECISION MEDICAL, INC. PM PUMP COMPRESSOR 10/28/1994
K902762 PRECISION MEDICAL, INC. PM14 SOFT AIR COMPRESSOR 07/30/1990
K945478 PREFERRED MEDICAL SUPPLY, INC. AM-50 AEROSOL/MEDICATION AIR COMPRESSOR 09/28/1995
K830417 PROFESSIONAL MEDICAL SUPPLY, INC. RESPI-NEB-AEROSOL SYSTEM 03/24/1983
K822512 REPCOCARTS USA, INC. REPCO EASY-BREATHER CLINICAL AIR PUMP 09/21/1982
K013027 RESPIRONICS HEALTHSCAN, INC. MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 12/06/2001
K864680 ROMAN LABORATORIES, INC. MOBIL 02 01/09/1987
K002468 SAN UP S.A. SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 03/02/2001
K023354 SIEMENS ELEMA AB COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E 09/05/2003
K871829 SIEMENS ELEMA AB SIEMENS DRY AIR COMPRESSOR 06/15/1987
K813311 THE BIOMED GROUP COMPRESSOR, AIR, PORTABLE 12/31/1981
K862628 THE JOHN BUNN CO. BUNN MODEL 510 MEDICATION COMPRESSOR 08/07/1986
K781213 THE JOHN BUNN CO. COMPRESSOR, AIR, MINI-SILENT 07/27/1978
K863339 THERA TEC, INC. DURA NEB(TM) 2000 PORTABLE COMPRESSOR 10/07/1986
K925011 THOMAS INDUSTRIES NEBULIZER PUMP, POWERED MODEL 1180 01/12/1994
K925010 THOMAS INDUSTRIES NEBULIZER PUMP, POWERED, MODEL 1110 05/27/1994
K771707 TIMETER INSTRUMENT CORP. ADIDYNE 3000 09/26/1977
K790912 TIMETER INSTRUMENT CORP. ARIDYNE 3500 05/21/1979
K812766 TIMETER INSTRUMENT CORP. PCS-5 ACCESSORIES 12/17/1981
K812767 TIMETER INSTRUMENT CORP. SNIFF AIR COMPRESSOR #SF-6 11/27/1981
K883132 TRAVELNEB, INC. NEBULIZER PUMP POWERED MODELS 020 AND 050 10/18/1988
K854747 TRAVOMED, INC. TRAVONEB MODEL # TONE 1 02/24/1986
K131881 TRUDELL MEDICAL INTL. OMBRA TABLE TOP COMPRESSOR 10/24/2013
K031413 VEGA TECHNOLOGIES, INC. VIGORMIST COMPRESSOR NEBULIZER 10/07/2003
K832072 VITA MEDICS VITA-MIST AIR COMPRESSOR & NEBULIZER 09/12/1983
K952616 WESTMED INTL. MICROTIME 09/27/1995


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