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

    TISSUE OXYGEN MONITOR SYSTEM, MODEL II

    K Number: K890624 · Decision Dec 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    22
    Applicant Total
    505
    Review Days
    318

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    Basic Information

    Device Name
    TISSUE OXYGEN MONITOR SYSTEM, MODEL II
    K Number
    K890624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1200
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    February 7, 1989
    Decision Date
    December 22, 1989
    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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