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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K872725
Device Name MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM
Applicant
Eyetronics, Inc.
4849 Grizzly Peak Blvd.
Berkeley,  CA  94705
Applicant Contact MARG, O.D.,PHD
Correspondent
Eyetronics, Inc.
4849 Grizzly Peak Blvd.
Berkeley,  CA  94705
Correspondent Contact MARG, O.D.,PHD
Regulation Number882.1890
Classification Product Code
GWE  
Date Received07/08/1987
Decision Date 08/14/1987
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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