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

    CORNING 184 BLOOD GAS TONOMETER

    K Number: K801599 · Decision Aug 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    111
    Review Days
    37

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    Basic Information

    Device Name
    CORNING 184 BLOOD GAS TONOMETER
    K Number
    K801599
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Corning Medical & Scientific
    Date Received
    July 14, 1980
    Decision Date
    August 20, 1980
    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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