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CCC — Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling Class II

FDA Device Classification

FDA product code CCC covers "Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling", a Class II medical device regulated under 21 CFR 868.1150. Submissions are reviewed by the Anesthesiology panel. At least 15 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
CCC
Device Class
Class II
Regulation Number
868.1150
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K071165alertis medicalISCALERT SENSOR SYSTEMNovember 7, 2007
K983198diametrics medicalTRENDCARE CALIBRATOR MODEL SCU 7007November 23, 1999
K972314diametrics medicalPARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIODecember 19, 1997
K953893biomedical sensorsPARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEMNovember 4, 1997
K961790optical sensorsPOINT-OF-CARE BLOOD GAS MONITOR SYSTEMApril 9, 1997
K963935optical sensorsOLYMPUS CRITICAL CARE MONITORING SYSTEMJanuary 23, 1997
K951094optical sensorsPOINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEMJanuary 16, 1996
K940188biomedical sensorsPARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEMNovember 13, 1995
K931185optical sensorsSENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTEOctober 21, 1993
K901548shileyBIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASJanuary 14, 1991
K891013medtronic vascularMEDTRONIC INTRAVASCULAR BLOOD GAS MONITORINGAugust 2, 1989
K870911american bentleyINDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALYMay 29, 1987
K780185siemensOXYGEN ANALYZER 110March 17, 1978
K771722biochem internationalSENSOMATSeptember 26, 1977
K760088ohio medical productsANALYZER, SENTORR BLOOD GASAugust 6, 1976

FDA data resources