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

    Modified BrainScope One

    K Number: K181785 · Decision Dec 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    3
    Review Days
    169

    Basic Information

    Device Name
    Modified BrainScope One
    K Number
    K181785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1450
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BrainScope Company Inc.
    Date Received
    July 3, 2018
    Decision Date
    December 19, 2018
    Product Code
    PIW
    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
    PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

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