FDA 510(k) Application Details - DEN170078

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170078
Device Name	Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
Applicant	Brainways Ltd. Bynet Bldg. P.O.B. 45169 19 Hartum Str. Har Hotzvim 9777518 IL Other 510(k) Applications for this Company
Contact	Ahava Stein 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	09/29/2017
Decision Date	08/17/2018
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review