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510(k) K051825

COGNITRACE by Eemagine Medical Imaging Solutions GmbH — Product Code GWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2005
Date Received
July 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

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