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

    Neurovision Nerve Locator Monitor (Nerveana), EMGView Software

    K Number: K170677 · Decision Apr 5, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
    K Number
    K170677
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neurovision Medical Product, Inc.
    Date Received
    March 6, 2017
    Decision Date
    April 5, 2017
    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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