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

    NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM

    K Number: K091457 · Decision Dec 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    2
    Review Days
    204

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    Basic Information

    Device Name
    NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
    K Number
    K091457
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nexstim OY
    Date Received
    May 18, 2009
    Decision Date
    December 8, 2009
    Product Code
    GWF
    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
    GWF Stimulator, Electrical, Evoked Response

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    Other Clearances by Nexstim OY

    K Number Device Name
    K112881 NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)