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510(k) Data Aggregation
K Number
K081591Device Name
NEUCODIA
Manufacturer
VERISCI CORPORATION
Date Cleared
2009-05-15
(343 days)
Product Code
GWE
Regulation Number
882.1890Why 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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