FDA 510(k) Application Details - K193006

Device Classification Name	More FDA Info for this Device
510(K) Number	K193006
Device Name	MagVenture TMS Therapy û for treatment of OCD, MagVenture TMS Therapy system
Applicant	Tonica Elektronik A/S Lucernemarken 15 Farum 3520 DK Other 510(k) Applications for this Company
Contact	Sanne Barsballe Jessen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QCI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2019
Decision Date	08/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review