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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transcranial magnetic stimulator
510(k) Number K171902
Device Name Nexstim Navigated Brain Therapy (NBT) System 2
Applicant
Nexstim Plc
Elimaenkatu 9b
Helsinki,  FI 00510
Applicant Contact Rainer Harjunpaa
Correspondent
Nexstim Plc
Elimaenkatu 9b
Helsinki,  FI 00510
Correspondent Contact Rainer Harjunpaa
Regulation Number882.5805
Classification Product Code
OBP  
Subsequent Product Codes
GWF   HAW   IKN  
Date Received06/26/2017
Decision Date 11/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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