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

    BrainScope Ahead 100

    K Number: DEN140025 · Decision Nov 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    8
    Review Days
    89

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    Basic Information

    Device Name
    BrainScope Ahead 100
    K Number
    DEN140025
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.1450
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Brainscope Company, Inc.
    Date Received
    August 20, 2014
    Decision Date
    November 17, 2014
    Product Code
    PIW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Expedited Review
    Y
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

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    Other Clearances by Brainscope Company, Inc.

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