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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K112353
Device Name GEODESIC EEG MOBILE 100 (GEM 100)
Applicant
ELECTRICAL GEODESICS, INC.
29611 SIMMONS ROAD
EUGENE,  OR  97405
Applicant Contact LINDA J BOVARD
Correspondent
ELECTRICAL GEODESICS, INC.
29611 SIMMONS ROAD
EUGENE,  OR  97405
Correspondent Contact LINDA J BOVARD
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received08/16/2011
Decision Date 02/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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