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

    BALANCEBACK MOBILE INTUITIVE VNG SYSTEM

    K Number: K070729 · Decision Mar 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    57
    Applicant Total
    2
    Review Days
    15

    Basic Information

    Device Name
    BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
    K Number
    K070729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FALL PREVENTION TECHNOLOGIES, LLC
    Date Received
    March 15, 2007
    Decision Date
    March 30, 2007
    Product Code
    GWN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    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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