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

    POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM

    K Number: K951094 · Decision Jan 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    7
    Review Days
    313

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    Basic Information

    Device Name
    POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM
    K Number
    K951094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optical Sensors, Inc.
    Date Received
    March 9, 1995
    Decision Date
    January 16, 1996
    Product Code
    CCC
    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
    CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

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