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

    PRECISION GAS MIXER

    K Number: K781417 · Decision Sep 20, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    14
    Review Days
    35

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    Basic Information

    Device Name
    PRECISION GAS MIXER
    K Number
    K781417
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medicor USA , Ltd.
    Date Received
    August 16, 1978
    Decision Date
    September 20, 1978
    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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