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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cortical
510(k) Number K992194
Device Name CORTICAL MAPPING UNIT, MODEL CMU
Applicant
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Applicant Contact JOHN F ZIOBRO
Correspondent
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Correspondent Contact JOHN F ZIOBRO
Regulation Number882.1310
Classification Product Code
GYC  
Date Received06/29/1999
Decision Date 09/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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