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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 K150641
Device Name MagVita TMS Therapy System
Applicant
TONICA ELEKTRONIK A/S
LUCERNEMARKEN 15
FARUM,  DK 3520
Applicant Contact Lise Terkelsen
Correspondent
TONICA ELEKTRONIK A/S
LUCERNEMARKEN 15
FARUM,  DK 3520
Correspondent Contact Lise Terkelsen
Regulation Number882.5805
Classification Product Code
OBP  
Date Received03/11/2015
Decision Date 07/31/2015
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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