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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 K852587
Device Name CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
Applicant
TRACOR NORTHERN, INC.
2551 WEST BELTLINE HWY
MIDDLETON,  WI  53562
Applicant Contact PATTY SONNTAG
Correspondent
TRACOR NORTHERN, INC.
2551 WEST BELTLINE HWY
MIDDLETON,  WI  53562
Correspondent Contact PATTY SONNTAG
Regulation Number882.1400
Classification Product Code
OLT  
Date Received06/18/1985
Decision Date 08/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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