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

    Monarch eTNS System

    K Number: DEN180041 · Decision Apr 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    263

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    Basic Information

    Device Name
    Monarch eTNS System
    K Number
    DEN180041
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.5898
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Neurosigma, Inc.
    Date Received
    July 30, 2018
    Decision Date
    April 19, 2019
    Product Code
    QGL
    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
    QGL Transcutaneous Nerve Stimulator For Adhd

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