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

    EVOKED POTENTIALS SYSTEM MK10

    K Number: K832510 · Decision Nov 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    8
    Review Days
    121

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    Basic Information

    Device Name
    EVOKED POTENTIALS SYSTEM MK10
    K Number
    K832510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Amplaid USA, Inc.
    Date Received
    July 27, 1983
    Decision Date
    November 25, 1983
    Product Code
    GWJ
    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
    GWJ Stimulator, Auditory, Evoked Response

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