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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name non-normalizing quantitative electroencephalograph software
510(k) Number K063797
Device Name GEODESIC EEG SYSTEM 300
Applicant
ELECTRICAL GEODESICS, INCORPORATED
29611 SIMMONS ROAD
EUGENE,  OR  97405
Applicant Contact LINDA J BOVARD
Correspondent
ELECTRICAL GEODESICS, INCORPORATED
29611 SIMMONS ROAD
EUGENE,  OR  97405
Correspondent Contact LINDA J BOVARD
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
GWQ  
Date Received12/22/2006
Decision Date 01/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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