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510(k) Data Aggregation

    K Number
    K060708
    Device Name
    SOMNOSCREEN
    Manufacturer
    SOMNOMEDICS GMBH & CO. KG
    Date Cleared
    2007-01-24

    (314 days)

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

    **SOMNOMEDICS GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOMNOscreen is a non-life-supporting portable physiological signal recording device intended to be used for testing adult patients suspected of having sleep-related breathing disorders. The SOMNOscreen is indicated for use in the recording, displaying, monitoring, and storage of biophysical parameters for the purpose of assisting in the diagnosis of Neurological and Sleep Disorders.
    Device Description
    The SOMNOscreen is a portable physiological signal recording system intended to be used to record, display, monitor, print and store biophysical events to aid in the diagnosis of neurologic and sleep disorders. The device is intended to be prescribed for use by a physician in the office, sleep laboratory or patient's home. This device is NOT designed to be used in a Life Support situation. This device is not designed for use on patients with cardiac pacemakers. The system provides up to 28 channels for data acquisition; 10 AC Channels, 8 Referential and 2 Differential, 11 Respiratory and AUX Channels, 7 Internal Channels (SPO2, Pulse Rate, Plethysmogram, Body Position, Light, Patient Marker, Thorax/Abdominal Respiratory Effort) The SOMNOscreen is available in 6 different configurations. All configurations include a Compact Flash Card and Reader, Li ION Batteries, (2000mAh) with 1 x Battery Charger, a Carry Bag for housing the SOMNOscreen and Sensors, Instruction Manuals and the DOMINO software for Initialization, Data Transfer and Analysis.
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