BEUDAMED
    Product Code: MNQ FDA class 3

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    Unknown

    The Implanted Hypoglossal Nerve Stimulator for Apnea is an implantable device that delivers electrical stimulation to the hypoglossal nerve to maintain upper airway patency during sleep, treating obstructive sleep apnea. Classified as FDA Class 3, it requires Premarket Approval (PMA) given its high-risk, implantable nature. The product code is MNQ, reviewed by the Anesthesiology panel, and carries an implant flag.

    View on FDA
    510(k)s
    0
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MNQ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    AN
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.