BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

    SEM Scanner (Model 200)

    K Number: DEN170021 · Decision Dec 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    626

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    Basic Information

    Device Name
    SEM Scanner (Model 200)
    K Number
    DEN170021
    Device Class
    FDA class 1
    Clearance Type
    Direct
    Regulation Number
    876.2100
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Bruin Biometrics, LLC
    Date Received
    April 3, 2017
    Decision Date
    December 20, 2018
    Product Code
    QEF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QEF Pressure Ulcer Management Tool