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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K002985
Device Name ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
Applicant
Ics Medical Corp.
125 Commerce Dr.
Schaumburg,  IL  60173 -5329
Applicant Contact DELMAR F BLOEM
Correspondent
Ics Medical Corp.
125 Commerce Dr.
Schaumburg,  IL  60173 -5329
Correspondent Contact DELMAR F BLOEM
Regulation Number882.1900
Classification Product Code
GWJ  
Subsequent Product Code
EWO  
Date Received09/25/2000
Decision Date 12/13/2000
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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