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510(k) Data Aggregation

    K Number
    K012976
    Device Name
    TWIN PLUS
    Manufacturer
    GRASS-TELEFACTOR DIVISON
    Date Cleared
    2002-02-12

    (160 days)

    Product Code
    OLV, GWQ
    Regulation Number
    882.1400
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    Applicant Name (Manufacturer) :

    GRASS-TELEFACTOR DIVISON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. Its specifications and features are especially well suited to electroencephilography, polysomnographic sleep recordings, and long term recordings used in epilepsy diagnosis. This software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. It is suitable for digital acquisition, display, comparison, analysis, and archiving of EEG potentials and other rapidly changing physiological parameters.
    Device Description
    TWin PLUS will become the universal review package for all GRASS-Telefactor EEG systems. Further the TWin PLUS software package is intended for use with a number of hardware EEG inourterlices. It utilizes the windows operating system to manage four or more simultaneous ongoing tasks which include: - Real-time collection and formating of real time EEG and other physiological parameters - Real-time display of the foregoing parameters in waveform or numeric format as the data and user . may require. - Real time analysis of EEG waveform data to identify events which may be epileptoform in nature and hence require special attention from professionals in attendance - SZAC analysis. - Data collection and recording to disk of real time video and audio data, usually an image of the patient ● being monitored. - Review and analysis of previously recorded data including the ability to look-back to old data while ● real-time recording of ongoing data is in progress.
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