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510(k) Data Aggregation

    K Number
    K240646
    Device Name
    DreamClear
    Manufacturer
    SomnoMed Technologies Inc., doing business as REMware
    Date Cleared
    2024-09-04

    (181 days)

    Product Code
    GWL, DQA, MNR
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    SomnoMed Technologies Inc., doing business as REMware

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DreamClear is intended for use on both adults and children to collect, amplify, and transmit physiological signals acquired from a patient, including electroencephalogram (EEG), electrooculography (EOG), limb movement, respiration effort, air pressure, and peripheral oxygen saturation (SpO2). DreamClear is intended for use on the order of a physician and is non-sterile. While primarily intended for use with dedicated polysomnography software to aid in the diagnosis of sleep disorders, DreamClear may be used to amplify physiological signals for any medical diagnostic procedure that does not involve: - use alone as an apnea monitor or as a critical component in an apnea monitoring system; or - use alone as a life support device or as a critical component of a life support system.
    Device Description
    DreamClear is a physiological signal amplifier and medical device data system that captures and streams various physiological parameters via Bluetooth for remote data analysis and diagnosis of sleep disorders. DreamClear features analog sensor interface circuits for Electroencephalograph (EEG), Electrooculography (EOG) and Electromyography (EMG) signals. Additionally, the device includes digital sensor interface circuits for nasal and oral airflow (breathing pattern), microphone (snoring), heart rate and blood oxygen saturation with pulse oximeter (SpO2). The DreamClear may be used in either a Basic Kit or Extended Kit configuration. The DreamClear device in its Basic Kit configuration includes the chest belt, pulse oximeter, and nasal cannula. The Basic Kit configuration has the following channels: thoracic effort, nasal pressure, pulse rate, SpO2, body position, and snore. The data recorded by the Basic Kit may be exported for optional display and analysis using third-party software products. When the DreamClear device is used in the Extended Kit configuration, the additional channels of EEG and EOG are used, which gives the DreamClear a total of eight (8) channels.
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