BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇧🇪 Belgium

    CEFALY

    K Number: DEN120019 · Decision Mar 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    453

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    Basic Information

    Device Name
    CEFALY
    K Number
    DEN120019
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    882.5891
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Stx-Med Sprl
    Date Received
    December 13, 2012
    Decision Date
    March 11, 2014
    Product Code
    PCC
    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
    PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

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