FDA 510(k) Applications for Medical Device Product Code "CCC"
(Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling)

FDA 510(k) Number Applicant Device Name Decision Date
K071165 ALERTIS MEDICAL AS ISCALERT SENSOR SYSTEM 11/07/2007
K870911 AMERICAN BENTLEY INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY 05/29/1987
K771722 BIOCHEM INTERNATIONAL, INC. SENSOMAT 09/26/1977
K953893 BIOMEDICAL SENSORS, INC. PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM 11/04/1997
K940188 BIOMEDICAL SENSORS, LTD. PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM 11/13/1995
K972314 DIAMETRICS MEDICAL, LTD. PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM 12/19/1997
K983198 DIAMETRICS MEDICAL, LTD. TRENDCARE CALIBRATOR MODEL SCU 7007 11/23/1999
K891013 MEDTRONIC VASCULAR MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING 08/02/1989
K760088 OHIO MEDICAL PRODUCTS ANALYZER, SENTORR BLOOD GAS 08/06/1976
K963935 OPTICAL SENSORS, INC. OLYMPUS CRITICAL CARE MONITORING SYSTEM 01/23/1997
K951094 OPTICAL SENSORS, INC. POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM 01/16/1996
K961790 OPTICAL SENSORS, INC. POINT-OF-CARE BLOOD GAS MONITOR SYSTEM 04/09/1997
K931185 OPTICAL SENSORS, INC. SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE 10/21/1993
K901548 SHILEY, INC. BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS 01/14/1991
K780185 SIEMENS CORP. OXYGEN ANALYZER 110 03/17/1978


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