BWF · Class II · 21 CFR 868.5690

FDA Product Code BWF: Spirometer, Therapeutic (incentive)

Leading manufacturers include Dhd Healthcare Corp., Health Products, Inc. and Dhd Medical Products Div. Diemolding Corp..

108
Total
108
Cleared
121d
Avg days
1976
Since
108 devices
49–72 of 108
Cleared Feb 08, 1996
MISTASSIST BREATHING EXERCISER
K953055
The Merlin Corp.
Anesthesiology · 223d
Cleared Apr 26, 1995
THE BREATHER
K944412
Pal Medical, Inc.
Anesthesiology · 230d
Cleared Feb 03, 1995
LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER
K944344
Lung Technologies, Inc.
Anesthesiology · 150d
Cleared Jan 13, 1995
EXPIRATORY BREATHING EXERCISER
K945118
Dhd Diemolding Healthcare Div.
Anesthesiology · 87d
Cleared Jan 06, 1995
THERAPEP
K944900
Dhd Diemolding Healthcare Div.
Anesthesiology · 94d
Cleared Sep 19, 1994
MERCURY EXPIRATORY RESISTANCE EXERCISER
K942919
Mercury Ent., Inc. D/B/A Mercury Medical
Anesthesiology · 90d
Cleared Jan 30, 1992
THRESHOLD 2X INSPIRATORY MUSCLE TRAINER
K912943
Health Products, Inc.
Anesthesiology · 209d
Cleared Mar 12, 1991
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138
Monaghan Medical Corp.
Anesthesiology · 57d
Cleared Dec 10, 1990
THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
K903489
Pegasus Research Corp.
Anesthesiology · 130d
Cleared Mar 15, 1990
RESPIREX 2
K900754
Diemolding Corp.
Anesthesiology · 27d
Cleared Aug 21, 1989
AEROSOL INHALATION MONITOR
K893665
Vitalograph , Ltd.
Anesthesiology · 98d
Cleared Feb 04, 1988
AEROBICA - LUNG EXERCISER
K873540
MBA Healthcare Products, Inc.
Anesthesiology · 156d
Cleared Dec 30, 1987
AMBU RMT VALVE
K873579
Ambu, Inc.
Anesthesiology · 118d
Cleared Jul 08, 1987
TOTAL LUNG EXERCISER (TLE)
K871904
MBA Healthcare Products, Inc.
Anesthesiology · 54d
Cleared Jun 15, 1987
MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER
K871742
Health Products, Inc.
Anesthesiology · 41d
Cleared Mar 31, 1987
THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
K870514
Health Products, Inc.
Anesthesiology · 54d
Cleared Mar 16, 1987
PFLEX EM(TM) (EXERCISE MONITOR)
K864719
Health Products, Inc.
Anesthesiology · 103d
Cleared Aug 07, 1986
THE LUNG GYM (XLATOR AND NLATOR)
K861564
El-Fax Company, Inc.
Anesthesiology · 104d
Cleared Aug 06, 1985
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K851334
American Pharmaseal Div. Ahsc
Anesthesiology · 127d
Cleared Jun 07, 1985
VITAPEP
K844963
Vitalograph , Ltd.
Anesthesiology · 165d
Cleared Aug 27, 1984
ELECATH INFANT ARTERIAL & VENOUS CANNU
K842369
Electro-Catheter Corp.
Anesthesiology · 73d
Cleared Aug 10, 1984
PFLEX RESPIRATORY MUSCLE EXERCISER
K842634
Health Scan, Inc.
Anesthesiology · 35d
Cleared Mar 05, 1984
VOFLEX
K840239
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 45d
Cleared Feb 17, 1984
INSPIRATORY/EXPIRATORY MUSCLE EXERCIS
K840418
Inspiron Corp.
Anesthesiology · 17d