BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    RETISCAN, RETIPORT

    K Number: K023525 · Decision Mar 26, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    522

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    Basic Information

    Device Name
    RETISCAN, RETIPORT
    K Number
    K023525
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.1890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roland Consult
    Date Received
    October 21, 2002
    Decision Date
    March 26, 2004
    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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