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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
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