BWF · Class II · 21 CFR 868.5690

FDA Product Code BWF: Spirometer, Therapeutic (incentive)

Leading manufacturers include Dhd Medical Products Div. Diemolding Corp., Dhd Healthcare Corp. and Chesebrough-Pond'S U.S.A. Co..

108
Total
108
Cleared
121d
Avg days
1976
Since
108 devices
25–48 of 108
Cleared Jan 11, 2000
FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
K992256
Intercontinental New Technologies, Inc.
Anesthesiology · 189d
Cleared Nov 10, 1999
ROADRUNNER, PEP THERAPY DEVICE
K991561
Dhd Healthcare Corp.
Anesthesiology · 190d
Cleared Jul 12, 1999
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
K991300
Dhd Healthcare Corp.
Anesthesiology · 87d
Cleared Jun 04, 1999
RC CORNET, MODEL #44F50
K983308
Pari Holding Co.
Anesthesiology · 256d
Cleared Jun 01, 1999
VITAL PEP
K984468
Vital Signs, Inc.
Anesthesiology · 167d
Cleared Apr 02, 1999
THERAPEP
K983467
Dhd Healthcare Corp.
Anesthesiology · 189d
Cleared Aug 06, 1998
MINI-CISER
K974848
Hougen Mfg., Inc.
Anesthesiology · 220d
Cleared Apr 03, 1998
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
K972824
Pn Medical
Anesthesiology · 247d
Cleared Aug 05, 1997
PARI PEP THERAPY SYSTEM
K972042
Pari Holding Co.
Anesthesiology · 64d
Cleared May 16, 1997
DHD EMERALD PRODUCT
K970596
Dhd Diemolding Healthcare Div.
Anesthesiology · 87d
Cleared Oct 21, 1996
MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
K954492
Mercury Medical
Anesthesiology · 390d
Cleared Oct 10, 1996
THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT
K962749
Diemolding Corp.
Anesthesiology · 87d
Cleared Jul 15, 1996
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
K961077
Healthscan Products, Inc.
Anesthesiology · 119d
Cleared Feb 08, 1996
MISTASSIST BREATHING EXERCISER
K953055
The Merlin Corp.
Anesthesiology · 223d
Cleared Mar 12, 1991
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138
Monaghan Medical Corp.
Anesthesiology · 57d
Cleared Aug 21, 1989
AEROSOL INHALATION MONITOR
K893665
Vitalograph , Ltd.
Anesthesiology · 98d
Cleared Dec 30, 1987
AMBU RMT VALVE
K873579
Ambu, Inc.
Anesthesiology · 118d
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 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
Cleared Nov 28, 1983
VOLUREX II
K833337
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 62d
Cleared Jun 03, 1983
INSPIRATORY RESISTOR KIT
K831142
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 57d