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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 K842964
Device Name PHOTIC STIMULATOR TM-3030-70
Applicant
Tracor Northern, Inc.
2551 W. Beltline Hwy.
Middleton,  WI  53562
Applicant Contact PHIL GETCHELL
Correspondent
Tracor Northern, Inc.
2551 W. Beltline Hwy.
Middleton,  WI  53562
Correspondent Contact PHIL GETCHELL
Regulation Number882.1890
Classification Product Code
GWE  
Date Received07/27/1984
Decision Date 12/28/1984
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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