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

    COGNIVUE

    K Number: DEN130033 · Decision Jun 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    723

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    Basic Information

    Device Name
    COGNIVUE
    K Number
    DEN130033
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.1470
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Cerebral Assessment Systems, Inc.
    Date Received
    June 12, 2013
    Decision Date
    June 5, 2015
    Product Code
    PKQ
    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
    PKQ Computerized Cognitive Assessment Aid

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