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 Cardiovascular Devices, Inc..

47
Total
47
Cleared
97d
Avg days
1981
Since
47 devices
25–47 of 47
Cleared Feb 17, 1995
MEDSAT OXYGEN SATURATION SYSTEM
K941922
Medtronic Bio-Medicus, Inc.
Cardiovascular · 303d
Cleared Nov 10, 1993
CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
K931968
3M Health Care, Ltd.
Cardiovascular · 203d
Cleared Jan 15, 1992
CDI(TM) 300, 400 & 100, MODIFICATION
K915255
3M Company
Cardiovascular · 58d
Cleared Jan 15, 1992
CDI(TM) H/S CUVETTE, MODIFICATION
K915265
3M Company
Cardiovascular · 57d
Cleared Oct 15, 1991
SATURATION/HEMATOCRIT MONITOR SYSTEM
K910421
Medtronic Vascular
Cardiovascular · 258d
Cleared Sep 14, 1990
GOLD GATORS
K903729
Lead-Lok, Inc.
Cardiovascular · 29d
Cleared Jul 31, 1990
APPLICARD (EKG)
K900459
Medi-Globe Corp.
Cardiovascular · 182d
Cleared Jul 31, 1990
PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE
K900682
Contour Electrodes, Inc.
Cardiovascular · 168d
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 Jun 18, 1987
GEM-CRIT CHECK
K871686
Diamond Sensor Systems
Cardiovascular · 50d
Cleared Jun 05, 1987
CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
K871221
Cardiovascular Devices, Inc.
Cardiovascular · 70d
Cleared Aug 25, 1986
CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE
K862953
Classic Medical Products, Inc.
Cardiovascular · 20d
Cleared Jul 18, 1986
CARDIOMET 4000 GAS MONITORING SYSTEMS
K862069
Biomedical Sensors, Inc.
Cardiovascular · 49d
Cleared Jun 02, 1986
CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000
K861277
Critichem, Inc.
Cardiovascular · 56d
Cleared Jan 08, 1986
GEM-6, WITH COMPONENTS
K854357
Diamond Electro-Tech, Inc.
Cardiovascular · 71d
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 Oct 18, 1984
PO 2 LYTRODE
K843538
Polystan C/O Vitalcor, Inc.
Cardiovascular · 41d
Cleared May 27, 1983
GAS-STAT MONITORING SYSTEM
K831225
Cardiovascular Devices, Inc.
Cardiovascular · 42d
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
Cleared Jul 20, 1981
OXIMETRIX ACCU SAT CPB
K811391
Oximetrix, Inc.
Cardiovascular · 63d