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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Spectrum, Electroencephalogram Signal
510(k) Number K894629
Device Name NICOLET BEAM II SYSTEM
Applicant
Nicolet Instrument Corp.
5225 Verona Rd.
Madison,  WI  53711
Applicant Contact T RIDDLE
Correspondent
Nicolet Instrument Corp.
5225 Verona Rd.
Madison,  WI  53711
Correspondent Contact T RIDDLE
Regulation Number882.1420
Classification Product Code
GWS  
Date Received07/24/1989
Decision Date 03/09/1990
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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