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510(k) Data Aggregation

    K Number
    K150102
    Device Name
    SnoreSounds
    Manufacturer
    APPIAN MEDICAL, INC.
    Date Cleared
    2015-11-05

    (289 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SnoreSounds software is indicated for use as an aid in the diagnostic evaluation of snoring in patients. The software provides quantitative and qualitative analysis of snoring.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "SnoreSounds." It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to your request.

    The letter acknowledges the device (K150102) and its intended use as an aid in the diagnostic evaluation of snoring, providing quantitative and qualitative analysis. The rest of the document is standard FDA regulatory boilerplate, including contact information and references to relevant regulations.

    Therefore, I cannot provide the detailed information requested in your prompt based on the provided text.

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