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

FDA 510(k) Number Applicant Device Name Decision Date
K140772 Actegy Ltd AEROSURE MEDIC 12/19/2014
K172388 Advanced Circulatory System, a wholly owned subsidiary of VPOD ITPR 12/22/2017
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 09/03/2014
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 06/11/2003
K770619 CUTTER LABORATORIES, INC. EXERCISOR, RESPIRATORY 04/07/1977
K160636 D R BURTON HEALTHCARE LLC iPEP System and vPEP 08/03/2016
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
K163091 Medica Holdings, LLC VibraPEP 02/21/2017
K153441 Medica Holdings, LLC VibraPEP 03/25/2016
K091557 MEDICAL ACOUSTICS LUNG FLUTE THERAPEUTIC 01/04/2010
K780037 MEDICAL TECHNOLOGIES OF GEORGIA EXERCISER, RESP., DEEP BREATHING 02/24/1978
K160837 MEDINET SRL MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM 02/23/2017
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
K150044 PARI RESPIRATORY EQUIPMENT, INC. O-PEP 05/27/2016
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
K150173 Trudell Medical International Aerobika OPEP Devive with Manometer 10/15/2015
K173918 Trudell Medical International VersaPAP Positive Airway Pressure (PAP) Device 08/17/2018
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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