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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
Predetermined Change
Control Plan Authorized		 No
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