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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 K260189
Device Name MagVenture Accelerated TMS (aTMS) Therapy System
Applicant
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK DK-3520
Applicant Contact Jan Kjøller
Correspondent
MagVenture A/S
Lucernemarken 15
Farum,  DK DK-3520
Correspondent Contact Kirstine Klitgaard Schou
Regulation Number882.5805
Classification Product Code
OBP  
Date Received01/22/2026
Decision Date 05/22/2026
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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