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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 K253098
Device Name Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
Applicant
Nexstim Oyj
Elimäenkatu 9b
Helsinki,  FI 00510
Applicant Contact Jarmo Laine
Correspondent
Nexstim Oyj
Elimäenkatu 9b
Helsinki,  FI 00510
Correspondent Contact Jarmo Laine
Regulation Number882.5805
Classification Product Code
OBP  
Subsequent Product Codes
GWF   IKN   QCI   QFF  
Date Received09/23/2025
Decision Date 03/20/2026
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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