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

    ADHERENT VISUAL STIMULATOR GOGGLES

    K Number: K113785 · Decision Jun 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    166

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    Basic Information

    Device Name
    ADHERENT VISUAL STIMULATOR GOGGLES
    K Number
    K113785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anschel Technology, Inc.
    Date Received
    December 23, 2011
    Decision Date
    June 6, 2012
    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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