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510(k) Data Aggregation

    K Number
    K100185
    Device Name
    SLEEP APP
    Manufacturer
    SLEEP MEDICINE NETWORK, INC.
    Date Cleared
    2010-11-19

    (301 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 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

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a medical device called "SleepApp™". It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The letter does not contain any information about acceptance criteria or performance studies of the device. It is a regulatory approval document based on the submission of a 510(k) premarket notification. Therefore, I cannot provide the requested information.

    The sections you've provided, {0}, {1}, and {2}, are standard FDA communication and an "Indications for Use Form." None of these sections detail acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies. These types of details would typically be found in the manufacturer's 510(k) submission itself, which is not provided here.

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