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

    NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)

    K Number: K083371 · Decision Dec 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    12
    Review Days
    389

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    Basic Information

    Device Name
    NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
    K Number
    K083371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Natus Medical, Inc.
    Date Received
    November 14, 2008
    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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