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

    SIEGEN VISUAL STIMULATOR

    K Number: K844616 · Decision Feb 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    48
    Applicant Total
    6
    Review Days
    79

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    Basic Information

    Device Name
    SIEGEN VISUAL STIMULATOR
    K Number
    K844616
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Siegen Corp.
    Date Received
    November 27, 1984
    Decision Date
    February 14, 1985
    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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    Other Clearances by Siegen Corp.

    K Number Device Name
    K871964 SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
    K861884 NEUROSCOPE SEEG
    K862430 SIEGEN HEADPHONES
    K844646 SIEGEN SURFACE ELECTRODES
    K843464 SIEGEN NEUROSCOPE