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510(k) Data Aggregation

    K Number
    K113569
    Device Name
    APNEARX
    Manufacturer
    APNEA SCIENCE CORPORATION
    Date Cleared
    2012-03-01

    (90 days)

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

    APNEA SCIENCE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apnea Sciences Corporation "ApneaRx" is intended for use on adult patients 18 years of age or older as an aid for the reduction of mild to moderate obstructive sleep apnea (OSA), and/or snoring.
    Device Description
    The Apnea Sciences Corporation ApneaRx is an intraoral device used at night to reduce mild to moderate obstructive sleep apnea, and/or snoring by advancing the lower jaw (mandibular repositioning) and thereby minimizing air obstruction and turbulence. The device consists of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth. This interface, and thus this device, functions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep.
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