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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 K923315
Device Name NICOLET ARK SYSTEM
Applicant
Nicolet Instrument Corp.
5225 Verona Rd.
Madison,  WI  53711
Applicant Contact DALE J THANIG
Correspondent
Nicolet Instrument Corp.
5225 Verona Rd.
Madison,  WI  53711
Correspondent Contact DALE J THANIG
Regulation Number882.1870
Classification Product Code
GWF  
Date Received07/07/1992
Decision Date 11/23/1992
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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