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

    Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

    K Number: K233293 · Decision Jan 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    109

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    Basic Information

    Device Name
    Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
    K Number
    K233293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5898
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurosigma, Inc.
    Date Received
    September 29, 2023
    Decision Date
    January 16, 2024
    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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