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510(k) Data Aggregation

    K Number
    K081591
    Device Name
    NEUCODIA
    Manufacturer
    VERISCI CORPORATION
    Date Cleared
    2009-05-15

    (343 days)

    Product Code
    GWE
    Regulation Number
    882.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERISCI CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neucodia system is an electrophysiological device that generates photic stimuli, and records, processes and analyzes the resultant visual evoked potential (VEP) signals for the study of central visual functions.
    Device Description
    Visual stimuli are presented to the patient on the stimulus monitor. Visual evoked potentials are extracted from EEG epochs recorded via medical-rated EEG electrodes (not included in the device) attached to the scalp of the patient. Once the recording is complete, the digitized EEG data are processed by the software algorithm for noise filtering, artifact rejection, frequency and time domain analysis. The results are displayed on the user's monitor: EEG epochs, spectrum, Fourier components, and statistical measures (e.g., means, deviations, and signal to noise ratio).
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