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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 K170114
Device Name MagVita TMS Therapy - w/MagPro R20
Applicant
TONICA ELEKTRONIK A/S
LUCERNEMARKEN 15
FARUM,  DK DK-3520
Applicant Contact LISE TERKELSEN
Correspondent
TONICA ELEKTRONIK A/S
LUCERNEMARKEN 15
FARUM,  DK DK-3520
Correspondent Contact LISE TERKELSEN
Regulation Number882.5805
Classification Product Code
OBP  
Date Received01/12/2017
Decision Date 05/01/2017
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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