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510(k) Data Aggregation

    K Number
    K173856
    Device Name
    Express 4 Sleep appliance/CPAP Sidekick appliance
    Manufacturer
    Moses Appliances LLC
    Date Cleared
    2018-06-26

    (188 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

    Express 4 Sleep appliance / CPAP Sidekick appliance is intended for use on adult patients 18 years of age and older for the temporary or trial treatment of snoring and mild to moderate obstructive sleep appliance / CPAP Sidekick appliance is intended to be used for a maximum of 30 days.

    Device Description

    Not Found

    AI/ML Overview

    This FDA 510(k) clearance letter (K173856) is for the Express 4 Sleep appliance / CPAP Sidekick appliance, which is an intraoral device for the treatment of snoring and mild to moderate obstructive sleep apnea.

    Unfortunately, the provided document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

    The 510(k) summary (which typically includes performance data and acceptance criteria) is a separate document from this clearance letter. This letter only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, meaning it has similar intended use and technological characteristics, and raises no new questions of safety or effectiveness.

    Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study as the provided text doesn't contain that information.

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