LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210636
    Device Name
    Morpheus
    Manufacturer
    S4S UK Ltd.
    Date Cleared
    2022-02-15

    (361 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the Morpheus device, an intraoral device for snoring and obstructive sleep apnea. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications necessary to answer your request.

    Therefore, I cannot fulfill your request using only the provided text. To answer your questions, I would need a detailed study report or a 510(k) summary that includes this information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1