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

    SIEGEN HEADPHONES

    K Number: K862430 · Decision Sep 26, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    6
    Review Days
    92

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    Basic Information

    Device Name
    SIEGEN HEADPHONES
    K Number
    K862430
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Siegen Corp.
    Date Received
    June 26, 1986
    Decision Date
    September 26, 1986
    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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    Other Clearances by Siegen Corp.

    K Number Device Name
    K871964 SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
    K861884 NEUROSCOPE SEEG
    K844616 SIEGEN VISUAL STIMULATOR
    K844646 SIEGEN SURFACE ELECTRODES
    K843464 SIEGEN NEUROSCOPE