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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K221544
Device Name MagVenture TMS Atlas Neuro Navigation System
Applicant
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK DK-3520
Applicant Contact Jan Kjoller
Correspondent
MagVenture A/S
Lucernemarken 15
Farum,  DK DK-3520
Correspondent Contact Alice K. Larsen
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/27/2022
Decision Date 03/17/2023
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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