BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇪 Ireland

    Lenire Tinnitus Treatment Device

    K Number: DEN210033 · Decision Mar 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    565

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    Basic Information

    Device Name
    Lenire Tinnitus Treatment Device
    K Number
    DEN210033
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    874.3410
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Neuromod Devices Limited
    Date Received
    August 18, 2021
    Decision Date
    March 6, 2023
    Product Code
    QVN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QVN Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus