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

    EVOKED RESPONSE SYS., MODEL 10

    K Number: K771742 · Decision Nov 22, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    68

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    Basic Information

    Device Name
    EVOKED RESPONSE SYS., MODEL 10
    K Number
    K771742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1845
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Grass Instrument Co.
    Date Received
    September 15, 1977
    Decision Date
    November 22, 1977
    Product Code
    GWK
    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
    GWK Conditioner, Signal, Physiological

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