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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K885246
Device Name ADVANTAGE
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 Number882.1870
Classification Product Code
GWF  
Date Received12/22/1988
Decision Date 02/27/1989
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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