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510(k) Data Aggregation

    K Number
    K210636
    Device Name
    Morpheus
    Manufacturer
    Date Cleared
    2022-02-15

    (361 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    S4S UK Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Morpheus is a prescription, patient-matched, mandibular repositioning device that is intended to reduce snoring or to treat mild to moderate obstructive sleep apnea. The device is intended for use by adult patients in either the home or sleep laboratory environment
    Device Description
    Not Found
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