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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
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