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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)
Original Applicant
NEXSTIM OY
elimaenkatu 9 b
helsinki,  FI fi-00510
Original 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 (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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