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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 K010669
Device Name NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1
Applicant
Thuris Corp.
110 Glenn Way #6
San Carlos,  CA  94070
Applicant Contact GRACE BARTOO
Correspondent
Thuris Corp.
110 Glenn Way #6
San Carlos,  CA  94070
Correspondent Contact GRACE BARTOO
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWE   GWJ  
Date Received03/06/2001
Decision Date 06/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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