Panels › Anesthesiology › Product code BWF · Class 2
Spirometer, Therapeutic (Incentive)
Regulation 868.5690
0510(k)s in 12 months (108 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in BWF
| Company | 510(k)s | Recalls |
|---|---|---|
| Dhd Healthcare Corp. | 5 | 0 |
| Dhd Medical Products Div. Diemolding Corp. | 4 | 0 |
| Health Products, Inc. | 4 | 0 |
| Advanced Circulatory Systems, Inc. | 3 | 0 |
| Chesebrough-Pond'S U.S.A. Co. | 3 | 0 |
| Dhd Diemolding Healthcare Div. | 3 | 0 |
| Trudell Medical International | 3 | 0 |
| Airlife, Inc. | 2 | 0 |
| Besmed Health Business Corp | 2 | 0 |
| D R Burton Healthcare, LLC | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 3, 1995 | K944344 | LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER Lung Technologies, Inc. | BWF |
| Jan 13, 1995 | K945118 | EXPIRATORY BREATHING EXERCISER Dhd Diemolding Healthcare Div. | BWF |
| Jan 6, 1995 | K944900 | THERAPEP Dhd Diemolding Healthcare Div. | BWF |
| Sep 19, 1994 | K942919 | MERCURY EXPIRATORY RESISTANCE EXERCISER Mercury Ent., Inc. D/B/A Mercury Medical | BWF |
| Jan 30, 1992 | K912943 | THRESHOLD 2X INSPIRATORY MUSCLE TRAINER Health Products, Inc. | BWF |
| Mar 12, 1991 | K910138 | TVS II ELECTRONIC INCENTIVE SPIROMETER Monaghan Medical Corp. | BWF |
| Dec 10, 1990 | K903489 | THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 Pegasus Research Corp. | BWF |
| Mar 15, 1990 | K900754 | RESPIREX 2 Diemolding Corp. | BWF |
| Aug 21, 1989 | K893665 | AEROSOL INHALATION MONITOR Vitalograph , Ltd. | BWF |
| Feb 4, 1988 | K873540 | AEROBICA - LUNG EXERCISER MBA Healthcare Products, Inc. | BWF |
| Dec 30, 1987 | K873579 | AMBU RMT VALVE Ambu, Inc. | BWF |
| Jul 8, 1987 | K871904 | TOTAL LUNG EXERCISER (TLE) MBA Healthcare Products, Inc. | BWF |
| Jun 15, 1987 | K871742 | MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER Health Products, Inc. | BWF |
| Mar 31, 1987 | K870514 | THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER Health Products, Inc. | BWF |
| Mar 16, 1987 | K864719 | PFLEX EM(TM) (EXERCISE MONITOR) Health Products, Inc. | BWF |
| Aug 7, 1986 | K861564 | THE LUNG GYM (XLATOR AND NLATOR) El-Fax Company, Inc. | BWF |
| Aug 6, 1985 | K851334 | AIRLIFE ELECTRONIC INCENTIVE SPIROMETER American Pharmaseal Div. Ahsc | BWF |
| Jun 7, 1985 | K844963 | VITAPEP Vitalograph , Ltd. | BWF |
| Aug 27, 1984 | K842369 | ELECATH INFANT ARTERIAL & VENOUS CANNU Electro-Catheter Corp. | BWF |
| Aug 10, 1984 | K842634 | PFLEX RESPIRATORY MUSCLE EXERCISER Health Scan, Inc. | BWF |
| Mar 5, 1984 | K840239 | VOFLEX Dhd Medical Products Div. Diemolding Corp. | BWF |
| Feb 17, 1984 | K840418 | INSPIRATORY/EXPIRATORY MUSCLE EXERCIS Inspiron Corp. | BWF |
| Nov 28, 1983 | K833337 | VOLUREX II Dhd Medical Products Div. Diemolding Corp. | BWF |
| Nov 8, 1983 | K833012 | INSPIROMETER Kinetix | BWF |
| Oct 14, 1983 | K832878 | GOAL TENDER Dna Medical, Inc. | BWF |
| Jun 3, 1983 | K831142 | INSPIRATORY RESISTOR KIT Dhd Medical Products Div. Diemolding Corp. | BWF |
| Sep 24, 1982 | K821492 | BE#6006 VAR. RESIS. INSPIR. MUSCLE Instrumentation Industries, Inc. | BWF |
| Aug 27, 1982 | K822359 | SPI-RISE Certified Respiratory Services, Inc. | BWF |
| Jul 30, 1982 | K821998 | RESPICORD Novamed Products, Inc. | BWF |
| Mar 26, 1982 | K820528 | PFLEX TM Health Scan, Inc. | BWF |
| Mar 23, 1982 | K820606 | MONAGHAN'S TRUE VOLUME EXERCISER Monaghan Medical Corp. | BWF |
| Dec 31, 1981 | K813476 | OHIO VOLUME INCENTIVE SPIROMETER Airco/Ohio Medical Products | BWF |
| May 13, 1981 | K810641 | K-MED ENCOURAGER INCENTIVE SPIROMETER K-Med, Inc. | BWF |
| Jun 4, 1980 | K801199 | VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX Chesebrough-Pond'S U.S.A. Co. | BWF |
| Mar 25, 1980 | K800546 | BUNN VOLUMAIRE RESPIRATORY EXERCISER The John Bunn Co. | BWF |
| Feb 28, 1980 | K800386 | ARGYLE TRU-VOL Sherwood Medical Co. | BWF |
| Jan 4, 1980 | K792598 | DISPOSABLE INCENTIVE SPIROMETER Hospitak, Inc. | BWF |
| Dec 19, 1979 | K792571 | COUNTER UNIT Empire Plastics Manufacturer | BWF |
| Nov 27, 1979 | K792217 | AIR INCENTIVE SPIROMETER, W/NEBULIZER Airlife, Inc. | BWF |
| Nov 27, 1979 | K792214 | MODEL TM2-BEHIND-THE-EAR TINNITUS Starkey Laboratories, Inc. | BWF |
| Oct 1, 1979 | K791842 | MOTIVATOR Puritan Bennett Corp. | BWF |
| Sep 26, 1979 | K791819 | AIR INCENTIVE SPIROMETER Airlife, Inc. | BWF |
| Jun 13, 1979 | K791015 | VOLUREX TM Dhd Medical Products Div. Diemolding Corp. | BWF |
| Apr 27, 1979 | K790744 | LUNG FUNCTION AMPLIFIER EXERCISER Empire Plastics Manufacturer | BWF |
| Dec 15, 1978 | K781831 | SPIROMETER, INCENTIVE CATALOG # 1750 Hudson Oxygen Therapy Sales Co. | BWF |
| Dec 13, 1978 | K782016 | SPIROCARE 108-B Marion Laboratories, Inc. | BWF |
| Dec 5, 1978 | K781731 | INCENT-O-NEB B & F Medical Products, Inc. | BWF |
| Nov 21, 1978 | K781838 | CALCULATOR, WITH CHARGER C.R. Bard, Inc. | BWF |
| Nov 14, 1978 | K781833 | EXERCISER, AIR-EZE INCENTIVE Chesebrough-Pond'S U.S.A. Co. | BWF |
| Oct 23, 1978 | K781669 | RESPIRATORY EXERCISOR, VOLUME PULSE Bd Becton Dickinson Vacutainer Systems Preanalytic | BWF |
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