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510(k) Data Aggregation

    K Number
    K093710
    Device Name
    THE MOSES APPLIANCE
    Manufacturer
    ALLEN J. MOSES, DDS, LTD.
    Date Cleared
    2010-05-12

    (161 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K121285
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Moses™ appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and/or alleviation of snoring and mild to moderate obstructive sleep apnea.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for "The Moses™ Appliance". It is a regulatory document and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document primarily focuses on:

    • Confirming that the device is substantially equivalent to legally marketed predicate devices.
    • Outlining the general controls and regulations the manufacturer must comply with.
    • Stating the intended use/indications for the device.

    Therefore, I cannot provide the requested information based on the given input.

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