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510(k) Data Aggregation

    K Number
    K073682
    Device Name
    EMBLETTA GOLD
    Manufacturer
    EMBLA SYSTEMS, INC.
    Date Cleared
    2008-08-08

    (224 days)

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

    EMBLA SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Embletta Gold is a digital recording device designed to be used under the direction of a physician or trained technician but applied by a layperson. The Embletta Gold records multiple physiological parameters for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel. The Embletta Gold is intended to be used for adult and pediatric (excluding neonatal and infant) studies. Note the recorder is not equipped with an alarm device and is not intended to be used as a life monitor. The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort.
    Device Description
    The Embletta GOLD polysomnographic recorder is intended for both clinical and research sleep applications, with 9 input channel capability of several types of physiological signals used by a physician or trained technician for the simultaneous acquisition of respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user triggered event and Oximetry parameters from a patient during sleep related studies. The device will be capable of a minimum of 24 hours of recording and saving all 9 input channels either to an internal memory or to a connected computer. The general intended environments are hospitals, institutions, sleep centers, sleep clinics, patient homes but the device should be capable of functioning in any environment where patients can sleep reasonably comfortably. The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria. The recorder does not provide any alarms and is not intended to be a monitor. A trained sleep technologist (polysomnographer) and a physician would typically review and analyze the recorded signals when downloaded and presented on a PC using a separate application software program.
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