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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K890495
Device Name NICOLET VIKING II SYSTEM
Applicant
NICOLET INSTRUMENT CORP.
5225 VERONA RD.
MADISON,  WI  53711
Applicant Contact RAYMOND T RIDDLE
Correspondent
NICOLET INSTRUMENT CORP.
5225 VERONA RD.
MADISON,  WI  53711
Correspondent Contact RAYMOND T RIDDLE
Regulation Number890.1375
Classification Product Code
IKN  
Date Received02/01/1989
Decision Date 03/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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