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510(k) Data Aggregation

    K Number
    K100185
    Device Name
    SLEEP APP
    Date Cleared
    2010-11-19

    (301 days)

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

    SLEEP MEDICINE NETWORK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SleepApp™ is intended for the treatment of snoring and mild to moderate obstructive sleep apnea in adults 18 years of age and older.
    Device Description
    Not Found
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