BZK · Class II · 21 CFR 868.1850

FDA Product Code BZK: Spirometer, Monitoring (w/wo Alarm)

Leading manufacturers include Respiratory Motion, Inc., Bear Medical Systems, Inc. and Ohmeda Medical.

61
Total
61
Cleared
107d
Avg days
1976
Since
61 devices
25–48 of 61
Cleared Mar 02, 1984
MEDISHIELD PVM RESPIROMETER
K840453
Ohio Medical Products
Anesthesiology · 30d
Cleared Jul 12, 1983
PORTABLE MONITORING & SCREENING SPIROM.
K822689
Boehringer Laboratories
Anesthesiology · 312d
Cleared May 09, 1983
SPIROMED RESPIROMETER
K831237
Draeger Medical, Inc.
Anesthesiology · 24d
Cleared Feb 24, 1983
COMPUTERIZED SPIROMETRY SYSTEM
K823922
Ohio Medical Products
Anesthesiology · 58d
Cleared Nov 16, 1982
BEAR VM-90 VENTILATION MONITOR
K822912
Bear Medical Systems, Inc.
Anesthesiology · 46d
Cleared May 08, 1980
RMS 111F RESPIRATORY MONITORING SYSTEM
K800086
The Perkin-Elmer Corp.
Anesthesiology · 115d
Cleared Jan 31, 1979
SPIROMETER, MINI POSITIVE
K782145
Boehringer Laboratories
Anesthesiology · 35d
Cleared Jan 31, 1978
SPIROMETER, MONITORING W/ALARM
K780064
Ohio Medical Products
Anesthesiology · 19d
Cleared Jul 05, 1977
SPIROMETEO EXHAUST
K770907
Timeter Instrument Corp.
Anesthesiology · 48d
Cleared Dec 09, 1976
POSITIVE DISPLACEMENT SPIROMETER
K760971
Boehringer Laboratories
Anesthesiology · 35d