BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BLOOD GAS CALIBRATION STANDARD

    K Number: K900819 · Decision Apr 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    63

    Basic Information

    Device Name
    BLOOD GAS CALIBRATION STANDARD
    K Number
    K900819
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    CRYOGENIC RARE GAS LABORATORIES, INC.
    Date Received
    February 21, 1990
    Decision Date
    April 25, 1990
    Product Code
    LCH
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCH Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical

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