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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 K903734
Device Name ADVANTAGE EP
Applicant
Clark Davis Medical Systems, Inc.
1764 Oxford St.
London, Ontario,  CA N5V 3R6
Applicant Contact MICHAEL CLARK
Correspondent
Clark Davis Medical Systems, Inc.
1764 Oxford St.
London, Ontario,  CA N5V 3R6
Correspondent Contact MICHAEL CLARK
Regulation Number882.1890
Classification Product Code
GWE  
Date Received08/16/1990
Decision Date 07/22/1991
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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