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510(k) Data Aggregation

    K Number
    K092942
    Device Name
    VITAL SLEEP
    Manufacturer
    THE SNORE RELIEVER COMPANY LLC
    Date Cleared
    2010-01-13

    (111 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

    The Vital Sleep™ mandibular advancement device is intended for the treatment of nighttime snoring in adults.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Vital Sleep™ device. This letter does not include information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices for treating nighttime snoring.

    Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval, not a scientific study report.

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