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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 K832084
Device Name EVOKED 3500 POTENTIAL SYSTEM
Applicant
Tracor Northern, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Tracor Northern, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1890
Classification Product Code
GWE  
Date Received06/28/1983
Decision Date 08/16/1983
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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