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510(k) Data Aggregation

    K Number
    K955841
    Device Name
    SLEEP SYSTEM FOR CLINICS & RESEARCH
    Manufacturer
    COMPUMEDICS PTD LTD.
    Date Cleared
    1997-03-11

    (445 days)

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

    COMPUMEDICS PTD LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compumedics Sleep Monitoring System is used as an aid in the diagnosis of sleep and respiratory related sleep disorders. The use of this sleep monitoring system is to be under the supervision of a physician, sleep technologist or clinician. The Compumedics Sleep Monitoring System is an information management tool to record, display, organise, redisplay (retrieve) and generate user-defined reports based on the subject's data received from monitoring devices typically used to evaluate sleep and sleep related respiratory disorders.
    Device Description
    The Compumedics Sleep Monitoring System is a device which integrates the monitoring and recording function of these individual devices, and provides the means to gather all these signals simultaneously into a single "box" where these signals can be viewed, stored, and retrieved in formats selected by the clinician or sleep technologist.
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