BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇬🇧 United Kingdom

    eXciteOSA with remote and eXciteOSA without remote

    K Number: DEN200018 · Decision Feb 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    318

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    Basic Information

    Device Name
    eXciteOSA with remote and eXciteOSA without remote
    K Number
    DEN200018
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    872.5575
    Medical Specialty
    Dental
    Decision
    Unknown
    Applicant
    Signifier Medical Technologies
    Date Received
    March 24, 2020
    Decision Date
    February 5, 2021
    Product Code
    QNO
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QNO Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QNO), ordered by most recent decision date.

    eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

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    eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

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    FDA Class 2 ·Dental
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