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

    MSAS PROFESSIONAL

    K Number: K993824 · Decision Jan 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    69

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    Basic Information

    Device Name
    MSAS PROFESSIONAL
    K Number
    K993824
    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
    November 12, 1999
    Decision Date
    January 20, 2000
    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
    K053004 MSAS-VANTAGE