BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INTRAVASCULAR BLOOD GAS SYSTEM

    K Number: K843912 · Decision Jan 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    99

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    Basic Information

    Device Name
    INTRAVASCULAR BLOOD GAS SYSTEM
    K Number
    K843912
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1200
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Devices, Inc.
    Date Received
    October 3, 1984
    Decision Date
    January 10, 1985
    Product Code
    CCE
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

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    Other Clearances by Cardiovascular Devices, Inc.

    K Number Device Name
    K890113 THE CDI(R) SYSTEM 400
    K884228 CDI(R) 2000 BLOOD GAS MONITOR
    K871221 CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
    K864703 MODIFIED GAS-STAT(TM) MONITORING SYSTEM
    K840749 GAST STAT MONITORING SYSTEM
    K831225 GAS-STAT MONITORING SYSTEM
    K822000 EXTRACORPOREAL BLOOD GAS SYSTEM