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
73–96 of 108
Cleared Nov 28, 1983
VOLUREX II
K833337
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 62d
Cleared Nov 08, 1983
INSPIROMETER
K833012
Kinetix
Anesthesiology · 63d
Cleared Oct 14, 1983
GOAL TENDER
K832878
Dna Medical, Inc.
Anesthesiology · 49d
Cleared Jun 03, 1983
INSPIRATORY RESISTOR KIT
K831142
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 57d
Cleared Sep 24, 1982
BE#6006 VAR. RESIS. INSPIR. MUSCLE
K821492
Instrumentation Industries, Inc.
Anesthesiology · 129d
Cleared Aug 27, 1982
SPI-RISE
K822359
Certified Respiratory Services, Inc.
Anesthesiology · 21d
Cleared Jul 30, 1982
RESPICORD
K821998
Novamed Products, Inc.
Anesthesiology · 23d
Cleared Mar 26, 1982
PFLEX TM
K820528
Health Scan, Inc.
Anesthesiology · 25d
Cleared Mar 23, 1982
MONAGHAN'S TRUE VOLUME EXERCISER
K820606
Monaghan Medical Corp.
Anesthesiology · 18d
Cleared Dec 31, 1981
OHIO VOLUME INCENTIVE SPIROMETER
K813476
Airco/Ohio Medical Products
Anesthesiology · 30d
Cleared May 13, 1981
K-MED ENCOURAGER INCENTIVE SPIROMETER
K810641
K-Med, Inc.
Anesthesiology · 64d
Cleared Jun 04, 1980
VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX
K801199
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 16d
Cleared Mar 25, 1980
BUNN VOLUMAIRE RESPIRATORY EXERCISER
K800546
The John Bunn Co.
Anesthesiology · 15d
Cleared Feb 28, 1980
ARGYLE TRU-VOL
K800386
Sherwood Medical Co.
Anesthesiology · 6d
Cleared Jan 04, 1980
DISPOSABLE INCENTIVE SPIROMETER
K792598
Hospitak, Inc.
Anesthesiology · 17d
Cleared Nov 27, 1979
MODEL TM2-BEHIND-THE-EAR TINNITUS
K792214
Starkey Laboratories, Inc.
Anesthesiology · 25d
Cleared Nov 27, 1979
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K792217
Airlife, Inc.
Anesthesiology · 22d
Cleared Oct 01, 1979
MOTIVATOR
K791842
Puritan Bennett Corp.
Anesthesiology · 12d
Cleared Sep 26, 1979
AIR INCENTIVE SPIROMETER
K791819
Airlife, Inc.
Anesthesiology · 12d
Cleared Jun 13, 1979
VOLUREX TM
K791015
Dhd Medical Products Div. Diemolding Corp.
Anesthesiology · 12d
Cleared Apr 27, 1979
LUNG FUNCTION AMPLIFIER EXERCISER
K790744
Empire Plastics Manufacturer
Anesthesiology · 11d
Cleared Dec 15, 1978
SPIROMETER, INCENTIVE CATALOG # 1750
K781831
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 46d
Cleared Dec 13, 1978
SPIROCARE 108-B
K782016
Marion Laboratories, Inc.
Anesthesiology · 8d
Cleared Dec 05, 1978
INCENT-O-NEB
K781731
B & F Medical Products, Inc.
Anesthesiology · 54d