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CCE — Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling Class II

FDA Device Classification

Classification Details

Product Code
CCE
Device Class
Class II
Regulation Number
868.1200
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K935778via medicalVIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEMDecember 5, 1996
K912145s and w medico teknikSYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIAMay 5, 1992
K910453baxter healthcareTOPS NEEDLE TIP PROBE & PVC TIP PROBEAugust 13, 1991
K905397puritan bennettPB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEMMay 14, 1991
K896311optex biomedicalOPTEX BLOOD GAS MONITORING SYSTEMJanuary 3, 1990
K890624baxter healthcareTISSUE OXYGEN MONITOR SYSTEM, MODEL IIDecember 22, 1989
K895149shileyNEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SYNovember 28, 1989
K895150shileyCONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORINGNovember 28, 1989
K884063c.r. bardBARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEMDecember 16, 1988
K875225ohmeda medicalUMBILICAL ARTERY OXYGEN SENSORMarch 4, 1988
K872896american bentleyUMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100February 12, 1988
K872125c.r. bardBARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEMDecember 11, 1987
K860808orange medical instrumentsCONTINUCATHMarch 13, 1986
K860106american bentleyOXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100February 26, 1986
K853786american bentleyOXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100October 16, 1985
K843912cardiovascular devicesINTRAVASCULAR BLOOD GAS SYSTEMJanuary 10, 1985
K840102m. d. softwareARTERIAL BLOOD GAS INTERPRETATION PROGFebruary 4, 1984
K832793orange medical instrumentsNEOCATH 1000 W/HEPCOTESeptember 26, 1983
K811071g.d. searle andVENOUS OXYGEN PROBEMay 5, 1981
K781271roche medical electronicsMONITOR, PO2, INTRAVASCULAROctober 12, 1978