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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 K182700
Device Name Nexstim Navigated Brain Therapy (NBT) System 2
Applicant
Nexstim Plc
Elimaenkatu 9b
Helsinki,  FI 00510
Applicant Contact Anna Honkanen
Correspondent
Nexstim Plc
Elimaenkatu 9b
Helsinki,  FI 00510
Correspondent Contact Anna Honkanen
Regulation Number882.5805
Classification Product Code
OBP  
Subsequent Product Codes
GWF   HAW   IKN  
Date Received09/27/2018
Decision Date 03/22/2019
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
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