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510(k) Data Aggregation

    K Number
    K083620
    Device Name
    SOMNOLYZER 24X7
    Manufacturer
    THE SIESTA GROUP NORTH AMERICA
    Date Cleared
    2009-03-06

    (88 days)

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

    THE SIESTA GROUP NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Somnolyzer 24X7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders. Somnolyzer 24X7 is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. This device is to be used under the supervision of a physician.
    Device Description
    Somnolyzer 24X7 is a software system for automatic analysis of sleep, respiratory and movement information recorded during sleep studies. It processes information recorded during sleep by electrodes and sensors attached to the body. It generates reports that include quantitative sleep, breathing and motion parameters, used to evaluate sleep and respiratory-related disorders.
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