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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 stimulation system for obsessive-compulsive disorder
510(k) Number K193006
Device Name MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
Applicant
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK 3520
Applicant Contact Sanne Barsballe Jessen
Correspondent
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK 3520
Correspondent Contact Sanne Barsballe Jessen
Regulation Number882.5802
Classification Product Code
QCI  
Subsequent Product Code
OBP  
Date Received10/28/2019
Decision Date 08/09/2020
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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