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510(k) Data Aggregation

    K Number
    K112102
    Device Name
    MICHELE SLEEP SCORING SYSTEMS
    Manufacturer
    YOUNES SLEEP TECHNOLOGIES
    Date Cleared
    2011-12-20

    (151 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    YOUNES SLEEP TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MICHELE Sleep Scoring System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.
    Device Description
    The MICHELE Sleep Scoring System (MICHELE) is a software system that scans physiological data obtained during level 1 sleep studies, referred to as polysomnography (PSG) records, and applies a variety of analytical approaches to identify the occurrence of certain events that relate to the presence and type of sleep state, breathing abnormalities and limb movements. The system scores Sleep Stages, Arousals, Respiratory Events and Leg Movements. At the end of the analysis the system generates a PSG Report that includes tables and graphs typical of those generated following manual scoring of PSG records by certified technologists. The results of the automated scoring may be displayed using a PSG Scoring Viewer application, which allows manual editing of the results and generation of a revised PSG Report. The device does not analyze data that are different from those analyzed by human scorers. It also neither interprets the results nor suggests a diagnosis.
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