FDA 510(k) Applications for Medical Device Product Code "BWF"
(Spirometer, Therapeutic (Incentive))

FDA 510(k) Number Applicant Device Name Decision Date
K070490 ADVANCED CIRCULATORY SYSTEMS, INC. CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) 06/20/2007
K040084 ADVANCED CIRCULATORY SYSTEMS, INC. LIFESTYLE CIRCULATORY ENHANCER 04/07/2004
K033401 ADVANCED CIRCULATORY SYSTEMS, INC. MODIFICATION TO RESQPOD CIRCULATORY ENHANCER 11/20/2003
K813476 AIRCO/OHIO MEDICAL PRODUCTS OHIO VOLUME INCENTIVE SPIROMETER 12/31/1981
K791819 AIRLIFE, INC. AIR INCENTIVE SPIROMETER 09/26/1979
K792217 AIRLIFE, INC. AIR INCENTIVE SPIROMETER, W/NEBULIZER 11/27/1979
K873579 AMBU, INC. AMBU RMT VALVE 12/30/1987
K851334 AMERICAN PHARMASEAL DIV. AHSC AIRLIFE ELECTRONIC INCENTIVE SPIROMETER 08/06/1985
K781731 B & F MEDICAL PRODUCTS, INC. INCENT-O-NEB 12/05/1978
K781669 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RESPIRATORY EXERCISOR, VOLUME PULSE 10/23/1978
K133873 BESMED HEALTH BUSINESS CORP. TRIBALL INCENTIVE SPIROMETER 04/04/2014
K141355 BESMED HEALTH BUSINESS CORPORATION VOLUMETRIC INCENTIVE SPIROMETER 9/3/2014
K771532 BOEHRINGER LABORATORIES SPIROMETEO & LUNG EXERCISER, 4601 08/26/1977
K781838 C.R. BARD, INC. CALCULATOR, WITH CHARGER 11/21/1978
K822359 CERTIFIED RESPIRATORY SERVICES, INC. SPI-RISE 08/27/1982
K781833 CHESEBROUGH-POND'S U.S.A. CO. EXERCISER, AIR-EZE INCENTIVE 11/14/1978
K780265 CHESEBROUGH-POND'S U.S.A. CO. FLOW REDUCING ANGULATION STAND 03/09/1978
K801199 CHESEBROUGH-POND'S U.S.A. CO. VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX 06/04/1980
K022906 CPRX LLC RESQPOD CIRCULATORY ENHANCER 02/12/2003
K770619 CUTTER LABORATORIES, INC. EXERCISOR, RESPIRATORY 04/07/1977
K970596 DHD DIEMOLDING HEALTHCARE DIV. DHD EMERALD PRODUCT 05/16/1997
K945118 DHD DIEMOLDING HEALTHCARE DIV. EXPIRATORY BREATHING EXERCISER 01/13/1995
K944900 DHD DIEMOLDING HEALTHCARE DIV. THERAPEP 01/06/1995
K002768 DHD HEALTHCARE CORP. ACAPELLA 12/05/2000
K991300 DHD HEALTHCARE CORP. BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE 07/12/1999
K003146 DHD HEALTHCARE CORP. CLINIFLO INCENTIVE SPIROMETER 11/21/2000
K991561 DHD HEALTHCARE CORP. ROADRUNNER, PEP THERAPY DEVICE 11/10/1999
K983467 DHD HEALTHCARE CORP. THERAPEP 04/02/1999
K791015 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. "VOLUREX TM" 06/13/1979
K831142 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. INSPIRATORY RESISTOR KIT 06/03/1983
K840239 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. VOFLEX 03/05/1984
K833337 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. VOLUREX II 11/28/1983
K900754 DIEMOLDING CORP. RESPIREX 2 03/15/1990
K962749 DIEMOLDING CORP. THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT 10/10/1996
K832878 DNA MEDICAL, INC. GOAL TENDER 10/14/1983
K760167 DYTEK CORP. BAG, POST OPERATIVE LUNG EXERCIZING BLOW 08/06/1976
K781245 DYTEK CORP. LUNG EXER. BAG, POST-OP, MODIFIED 09/20/1978
K861564 EL-FAX COMPANY, INC. THE LUNG GYM (XLATOR AND NLATOR) 08/07/1986
K842369 ELECTRO-CATHETER CORP. ELECATH INFANT ARTERIAL & VENOUS CANNU 08/27/1984
K792571 EMPIRE PLASTICS MANUFACTURER COUNTER UNIT 12/19/1979
K790744 EMPIRE PLASTICS MANUFACTURER LUNG FUNCTION AMPLIFIER EXERCISER 04/27/1979
K000314 ENGINEERED MEDICAL SYSTEMS INCENTIVE SPIROMETER 04/12/2000
K080299 EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH RESPIFIT S, MODEL RS-LR1001004 01/13/2009
K871742 HEALTH PRODUCTS, INC. MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER 06/15/1987
K864719 HEALTH PRODUCTS, INC. PFLEX EM(TM) (EXERCISE MONITOR) 03/16/1987
K912943 HEALTH PRODUCTS, INC. THRESHOLD 2X INSPIRATORY MUSCLE TRAINER 01/30/1992
K870514 HEALTH PRODUCTS, INC. THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER 03/31/1987
K961077 HEALTHSCAN PRODUCTS, INC. PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE 07/15/1996
K842634 HEALTHSCAN, INC. PFLEX RESPIRATORY MUSCLE EXERCISER 08/10/1984
K820528 HEALTHSCAN, INC. PFLEX TM 03/26/1982
K792598 HOSPITAK, INC. DISPOSABLE INCENTIVE SPIROMETER 01/04/1980
K974848 HOUGEN MFG., INC. MINI-CISER 08/06/1998
K781831 HUDSON OXYGEN THERAPY SALES CO. SPIROMETER, INCENTIVE CATALOG # 1750 12/15/1978
K760762 I-SPIRON INCENTIVE SPIROMETER 10/08/1976
K840418 INSPIRON CORP. INSPIRATORY/EXPIRATORY MUSCLE EXERCIS 02/17/1984
K821492 INSTRUMENTATION INDUSTRIES, INC. BE#6006 VAR. RESIS. INSPIR. MUSCLE 09/24/1982
K992256 INTERCONTINENTAL NEW TECHNOLOGIES, INC. FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01 01/11/2000
K810641 K-MED, INC. K-MED "ENCOURAGER" INCENTIVE SPIROMETER 05/13/1981
K833012 KINETIX INSPIROMETER 11/08/1983
K053149 LEVENTON, S.A. SPIRO-BALL 12/13/2005
K994074 LEVENTON, S.A. TRI-BALL 06/08/2000
K944344 LUNG TECHNOLOGIES, INC. LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER 02/03/1995
K782016 MARION LABORATORIES, INC. SPIROCARE 108-B 12/13/1978
K873540 MBA HEALTHCARE PRODUCTS, INC. AEROBICA - LUNG EXERCISER 02/04/1988
K871904 MBA HEALTHCARE PRODUCTS, INC. TOTAL LUNG EXERCISER (TLE) 07/08/1987
K770141 MEDI, INC. INSPIROMETER RESPIRATORY EXERCISER 02/01/1977
K091557 MEDICAL ACOUSTICS LUNG FLUTE THERAPEUTIC 01/04/2010
K780037 MEDICAL TECHNOLOGIES OF GEORGIA EXERCISER, RESP., DEEP BREATHING 02/24/1978
K942919 MERCURY ENT., INC. D/B/A MERCURY MEDICAL MERCURY EXPIRATORY RESISTANCE EXERCISER 09/19/1994
K954492 MERCURY MEDICAL MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX 10/21/1996
K820606 MONAGHAN MEDICAL CORP. MONAGHAN'S TRUE VOLUME EXERCISER 03/23/1982
K910138 MONAGHAN MEDICAL CORP. TVS II ELECTRONIC INCENTIVE SPIROMETER 03/12/1991
K821998 NOVAMED PRODUCTS, INC. RESPICORD 07/30/1982
K944412 PAL MEDICAL, INC. THE BREATHER 04/26/1995
K972042 PARI HOLDING CO. PARI PEP THERAPY SYSTEM 08/05/1997
K983308 PARI HOLDING CO. RC CORNET, MODEL #44F50 06/04/1999
K090829 PARI RESPIRATORY EQUIPMENT, INC. PARI PEP S 07/21/2009
K903489 PEGASUS RESEARCH CORP. THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 12/10/1990
K972824 PN MEDICAL THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER 04/03/1998
K791842 PURITAN BENNETT CORP. MOTIVATOR 10/01/1979
K800386 SHERWOOD MEDICAL CO. ARGYLE TRU-VOL 02/28/1980
K792214 STARKEY LABORATORIES, INC. MODEL TM2-BEHIND-THE-EAR TINNITUS 11/27/1979
K800546 THE JOHN BUNN CO. BUNN VOLUMAIRE RESPIRATORY EXERCISER 03/25/1980
K953055 THE MERLIN CORP. MISTASSIST BREATHING EXERCISER 02/08/1996
K123400 TRUDELL MEDICAL INTL. AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE 05/16/2013
K012368 TRUDELL MEDICAL INTL. AEROPEP 02/12/2002
K984468 VITAL SIGNS, INC. VITAL PEP 06/01/1999
K893665 VITALOGRAPH LTD. AEROSOL INHALATION MONITOR 08/21/1989
K844963 VITALOGRAPH LTD. VITAPEP 06/07/1985


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