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

    VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM

    K Number: K072254 · Decision Feb 5, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    58
    Applicant Total
    17
    Review Days
    175

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    Basic Information

    Device Name
    VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
    K Number
    K072254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interacoustics A/S
    Date Received
    August 14, 2007
    Decision Date
    February 5, 2008
    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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