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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 K043309
Device Name GEODESIC PHOTOGRAMMETRY SYSTEM
Applicant
Electrical Geodesics, Incorporated
29611 Simmons Rd.
Eugene,  OR  97405
Applicant Contact LINDA J BOVARD
Correspondent
Electrical Geodesics, Incorporated
29611 Simmons Rd.
Eugene,  OR  97405
Correspondent Contact LINDA J BOVARD
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
KQM  
Date Received12/01/2004
Decision Date 01/26/2005
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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