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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K850109
Device Name NOMAD TM-3400
Applicant
TRACOR NORTHERN, INC.
2551 WEST BELTLINE HWY
MIDDLETON,  WI  53562
Applicant Contact JOHN GERICKE
Correspondent
TRACOR NORTHERN, INC.
2551 WEST BELTLINE HWY
MIDDLETON,  WI  53562
Correspondent Contact JOHN GERICKE
Regulation Number882.1870
Classification Product Code
GWF  
Date Received01/14/1985
Decision Date 06/04/1985
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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