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

    EVOKED POTENTIAL SYSTEM 2000

    K Number: K831651 · Decision Sep 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    112

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    Basic Information

    Device Name
    EVOKED POTENTIAL SYSTEM 2000
    K Number
    K831651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Ophthalmetric Corp.
    Date Received
    May 23, 1983
    Decision Date
    September 12, 1983
    Product Code
    GWE
    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
    GWE Stimulator, Photic, Evoked Response

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