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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K874733
Device Name GUARDIAN, EEG BRAIN MONITORING SYSTEM
Applicant
Tracor Northern, Inc.
2551 W. Beltline Hwy.
Middleton,  WI  53562
Applicant Contact KENNETH R WINDISCH
Correspondent
Tracor Northern, Inc.
2551 W. Beltline Hwy.
Middleton,  WI  53562
Correspondent Contact KENNETH R WINDISCH
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
OMC  
Date Received11/18/1987
Decision Date 02/29/1988
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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