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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 K112881
Device Name NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
Applicant
Nexstim OY
Elimaenkatu 9 B
Helsinki,  FI FI-00510
Applicant Contact RAINER HARJUNPAA
Correspondent
Nexstim OY
Elimaenkatu 9 B
Helsinki,  FI FI-00510
Correspondent Contact RAINER HARJUNPAA
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
HAW   IKN  
Date Received09/30/2011
Decision Date 05/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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