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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 K171967
Device Name MagVita TMS Therapy System
Applicant
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK
Applicant Contact Lise Terkelsen
Correspondent
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK
Correspondent Contact Lise Terkelsen
Regulation Number882.5805
Classification Product Code
OBP  
Date Received06/30/2017
Decision Date 07/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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