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

    MSAS-VANTAGE

    K Number: K053004 · Decision Jan 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    79

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    Basic Information

    Device Name
    MSAS-VANTAGE
    K Number
    K053004
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1540
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomeridian, Int.
    Date Received
    October 26, 2005
    Decision Date
    January 13, 2006
    Product Code
    GZO
    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
    GZO Device, Galvanic Skin Response Measurement

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    Other Clearances by Biomeridian, Int.

    K Number Device Name
    K993824 MSAS PROFESSIONAL