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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 K172667
Device Name MagVita TMS Therapy w/MagPro R20
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK 3520
Applicant Contact Lise Terkelsen
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK 3520
Correspondent Contact Lise Terkelsen
Regulation Number882.5805
Classification Product Code
Date Received09/05/2017
Decision Date 10/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No