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

    HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER

    K Number: K802379 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    31

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    Basic Information

    Device Name
    HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER
    K Number
    K802379
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Instrument Co.
    Date Received
    September 30, 1980
    Decision Date
    October 31, 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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