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

    CEREBRAL FUNCTION MONITOR 870

    K Number: K791580 · Decision Sep 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    22
    Review Days
    18

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    Basic Information

    Device Name
    CEREBRAL FUNCTION MONITOR 870
    K Number
    K791580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Applied Medical Research
    Date Received
    August 17, 1979
    Decision Date
    September 4, 1979
    Product Code
    OMA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OMA Amplitude-Integrated Electroencephalograph

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