DRY · Class II · 21 CFR 870.4330

FDA Product Code DRY: Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

Leading manufacturers include Spectrum Medical , Ltd., 3M Company and International Biophysics Corp..

47
Total
47
Cleared
97d
Avg days
1981
Since
47 devices
25–47 of 47
Cleared May 24, 1988
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
K881006
Shiley, Inc.
Cardiovascular · 76d
Cleared May 13, 1988
STAT-SAT
K874839
Gish Biomedical, Inc.
Cardiovascular · 171d
Cleared Sep 16, 1985
HEMATOCRIT-SATURATION MONITOR HSM-100
K852124
American Bentley
Cardiovascular · 124d
Cleared Oct 24, 1984
COBE SATURATION CELL
K843709
Cobe Laboratories, Inc.
Cardiovascular · 33d
Cleared Jan 05, 1983
OXYGEN CONSUMPTION MONITOR #OCM-0100
K823359
Bentley Laboratories, Inc.
Cardiovascular · 61d
Cleared May 25, 1982
IN-LINE OXYGEN MONITORING SYSTEM
K821159
G.D. Searle and Co.
Cardiovascular · 33d