BWF · Class II · 21 CFR 868.5690

FDA Product Code BWF: Spirometer, Therapeutic (incentive)

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

108
Total
108
Cleared
121d
Avg days
1976
Since
108 devices
25–48 of 108
Cleared Jan 13, 2009
RESPIFIT S, MODEL RS-LR1001004
K080299
Eumedics Medizintechnik Und Marketing GmbH
Anesthesiology · 343d
Cleared Jun 20, 2007
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
K070490
Advanced Circulatory Systems, Inc.
Anesthesiology · 120d
Cleared Dec 13, 2005
SPIRO-BALL
K053149
Leventon, S.A.
Anesthesiology · 33d
Cleared Apr 07, 2004
LIFESTYLE CIRCULATORY ENHANCER
K040084
Advanced Circulatory Systems, Inc.
Anesthesiology · 83d
Cleared Nov 20, 2003
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
K033401
Advanced Circulatory Systems, Inc.
Anesthesiology · 27d
Cleared Jun 11, 2003
RESQPOD CIRCULATORY ENHANCER
K022906
Cprx, LLC
Anesthesiology · 281d
Cleared Feb 12, 2002
AEROPEP
K012368
Trudell Medical Intl.
Anesthesiology · 201d
Cleared Dec 05, 2000
ACAPELLA
K002768
Dhd Healthcare Corp.
Anesthesiology · 90d
Cleared Nov 21, 2000
CLINIFLO INCENTIVE SPIROMETER
K003146
Dhd Healthcare Corp.
Anesthesiology · 42d
Cleared Jun 08, 2000
TRI-BALL
K994074
Leventon, S.A.
Anesthesiology · 189d
Cleared Apr 12, 2000
INCENTIVE SPIROMETER
K000314
Engineered Medical Systems
Anesthesiology · 71d
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