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 |