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510(k) Data Aggregation

    K Number
    K202621
    Device Name
    NeuroSENSE Monitoring System, Model NS-901
    Manufacturer
    NeuroWave Systems Inc.
    Date Cleared
    2021-08-05

    (329 days)

    Product Code
    OLW, GXY, OLT, OMC, ORT
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroWave Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroSENSE Monitoring System, Model NS-901, is intended for monitoring the brain state of adult and pediatric patients (18 years of age and older) in the operating room and other clinical settings by acquiring electroencephalographic (EEG) signals. The WAVCNs index, a quantifier of EEG activity calculated and displayed by the NeuroSENSE NS-901 Monitor, may be used as an aid in monitoring the hypnotic effect of anesthetics. The anesthetics include inhaled anesthetics and propofol in combination with opioids. The NeuroSENSE Monitor is intended to be used under the direction and interpretation of a qualified medical professional.
    Device Description
    The NeuroSENSE Monitoring System, Model NS-901, is a 2-channel bilateral processed Electroencephalograph (EEG) monitor for brain function monitoring in the operating room and other clinical settings. The acquired EEG waveforms and processed EEG variables are continuously displayed by the system for interpretation by a qualified medical professional and for use as a supplement to the anesthesia standard of care. The user interacts with the system via a touch screen interface. The NS-901 System consists of the following main components: - Display Module (DM-901) processes acquired EEG signals, displays EEG waveforms . and processed EEG variables, and archives them for later review - EEG Module (EM-901) - 1) acquires analog EEG signals through the integrated Patient Cable connected to electrodes on a patient's forehead, - 2) converts acquired analog EEG signals into digital EEG signals, and - 3) sends the digital EEG signals to the Display Module through the integrated Data Cable - EasyPrep Sensor Kit (EK-901) Noninvasive, disposable, single-use patient electrodes ● for acquiring the EEG signal The NeuroSENSE Monitoring System displays EEG waveforms and the following EEG processed variables and plots for each EEG channel: - Wavelet-based Anesthetic Value for Central Nervous System (WAVCNS) ● - . Electromyogram (EMG) - Suppression Ratio (SR) ● - Spectral parameters: Density Spectral Array (DSA), Median Edge Frequency (MEF), ● Spectral Edge Frequency (SEF), and spectral powers in different EEG frequency bands For improved reliability, the NeuroSENSE employs circuitry and algorithms for automatic detection, removal and/or filtering of physiological and environmental artifacts that commonly contaminate EEG signals. The NS-901 System also performs self-tests, automatic calibration of the amplifiers and continuous check of the electrode-skin contacts to ensure proper operation and optimal signal quality. Signal quality indicators (electrode status, 50/60 Hz noise level, artifact status) as well as system alarms, notifications and other related messages are displayed by the system. The system also provides protection for the operator and patient during cardiac defibrillation.
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    K Number
    K142834
    Device Name
    DiscoverEEG System, Model DE-401
    Manufacturer
    NeuroWave Systems Inc.
    Date Cleared
    2015-06-23

    (266 days)

    Product Code
    OLT, OMC
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroWave Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DiscoverEEG System, Model DE-401 is intended to be used for measuring and recording the electrical activity of a subject's brain, obtained by placing non-invasive electrodes on the head. The DiscoverEEG, DE-401 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and at home and for clinical research. The medical use of data acquired by the DiscoverEEG is to be performed under the direction and interpretation of a licensed medical professional. The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition.
    Device Description
    The DiscoverEEG System, Model DE-401, is a wearable, medical-grade EEG device that acquires and stores up to four electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a subject's head. The acquired EEG waveforms, as well as, processed EEG spectral variables are continuously stored by the system for later retrieval. The data can be transferred from the DiscoverEEG hardware to a computer for review. The DiscoverEEG System, Model DE-401 has four main components: Acquisition Module, Memory Module, Disposable Electrode Array, and Data Viewer Software.
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