CCC · Class II · 21 CFR 868.1150

FDA Product Code CCC: Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

Leading manufacturers include Optical Sensors, Inc., Diametrics Medical, Ltd. and Biochem International, Inc..

15
Total
15
Cleared
260d
Avg days
1976
Since

FDA 510(k) Cleared Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling Devices (Product Code CCC)

15 devices
1–15 of 15
Cleared Nov 07, 2007
ISCALERT SENSOR SYSTEM
K071165
Alertis Medical AS
Anesthesiology · 195d
Cleared Nov 23, 1999
TRENDCARE CALIBRATOR MODEL SCU 7007
K983198
Diametrics Medical, Ltd.
Anesthesiology · 438d
Cleared Dec 19, 1997
PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM
K972314
Diametrics Medical, Ltd.
Anesthesiology · 182d
Cleared Nov 04, 1997
PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
K953893
Biomedical Sensors, Inc.
Anesthesiology · 810d
Cleared Apr 09, 1997
POINT-OF-CARE BLOOD GAS MONITOR SYSTEM
K961790
Optical Sensors, Inc.
Anesthesiology · 335d
Cleared Jan 23, 1997
OLYMPUS CRITICAL CARE MONITORING SYSTEM
K963935
Optical Sensors, Inc.
Anesthesiology · 114d
Cleared Jan 16, 1996
POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM
K951094
Optical Sensors, Inc.
Anesthesiology · 313d
Cleared Nov 13, 1995
PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
K940188
Biomedical Sensors, Ltd.
Anesthesiology · 669d
Cleared Oct 21, 1993
SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE
K931185
Optical Sensors, Inc.
Anesthesiology · 226d
Cleared Jan 14, 1991
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
K901548
Shiley, Inc.
Anesthesiology · 286d
Cleared Aug 02, 1989
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
K891013
Medtronic Vascular
Anesthesiology · 155d
Cleared May 29, 1987
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
K870911
American Bentley
Anesthesiology · 84d
Cleared Mar 17, 1978
OXYGEN ANALYZER 110
K780185
Siemens Corp.
Anesthesiology · 39d
Cleared Sep 26, 1977
SENSOMAT
K771722
Biochem International, Inc.
Anesthesiology · 13d
Cleared Aug 06, 1976
ANALYZER, SENTORR BLOOD GAS
K760088
Ohio Medical Products
Anesthesiology · 46d

About Product Code CCC - Regulatory Context