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

FDA 510(k) Number Applicant Device Name Decision Date
K860106 AMERICAN BENTLEY OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 02/26/1986
K853786 AMERICAN BENTLEY OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 10/16/1985
K872896 AMERICAN BENTLEY UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 02/12/1988
K890624 BAXTER HEALTHCARE CORP. TISSUE OXYGEN MONITOR SYSTEM, MODEL II 12/22/1989
K910453 BAXTER HEALTHCARE CORP. TOPS NEEDLE TIP PROBE & PVC TIP PROBE 08/13/1991
K884063 C.R. BARD, INC. BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM 12/16/1988
K872125 C.R. BARD, INC. BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM 12/11/1987
K843912 CARDIOVASCULAR DEVICES, INC. INTRAVASCULAR BLOOD GAS SYSTEM 01/10/1985
K811071 G.D. SEARLE AND CO. VENOUS OXYGEN PROBE 05/05/1981
K840102 M. D. SOFTWARE, INC. ARTERIAL BLOOD GAS INTERPRETATION PROG 02/04/1984
K875225 OHMEDA MEDICAL UMBILICAL ARTERY OXYGEN SENSOR 03/04/1988
K896311 OPTEX BIOMEDICAL OPTEX BLOOD GAS MONITORING SYSTEM 01/03/1990
K860808 ORANGE MEDICAL INSTRUMENTS, INC. CONTINUCATH 03/13/1986
K832793 ORANGE MEDICAL INSTRUMENTS, INC. NEOCATH 1000 W/HEPCOTE 09/26/1983
K905397 PURITAN BENNETT CORP. PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM 05/14/1991
K781271 ROCHE MEDICAL ELECTRONICS, INC. MONITOR, PO2, INTRAVASCULAR 10/12/1978
K912145 S & W MEDICO TEKNIK SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA 05/05/1992
K771116 SHERWOOD MEDICAL INDUSTRIES CATHETER, PO2, INTRAVASUCLAR, CITADEL 09/15/1977
K760350 SHERWOOD MEDICAL INDUSTRIES MONITOR, CITADEL INTRAVASCULAR PO2 10/29/1976
K895150 SHILEY, INC. CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING 11/28/1989
K895149 SHILEY, INC. NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY 11/28/1989
K935778 VIA MEDICAL CORP. VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM 12/05/1996
K780850 WILL ROSS CO. SEARLE NEONATAL OXYGEN PROBE 08/23/1978


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