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

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

    K Number: K240328 · Decision May 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
    K Number
    K240328
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.5575
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Signifier Medical Technologies, Ltd.
    Date Received
    February 5, 2024
    Decision Date
    May 16, 2024
    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)

    FDA 510(k)
    FDA Class 2 ·Dental

    eXciteOSA with remote and eXciteOSA without remote

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Signifier Medical Technologies, Ltd.

    K Number Device Name
    K223446 eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)