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

    NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM

    K Number: K130201 · Decision Apr 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    58
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
    K Number
    K130201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ototronix, LLC
    Date Received
    January 28, 2013
    Decision Date
    April 26, 2013
    Product Code
    GWN
    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
    GWN Nystagmograph

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