FDA 510(k) Application Details - K203616

Device Classification Name	More FDA Info for this Device
510(K) Number	K203616
Device Name	Brainsway Deep (DTMS) System
Applicant	Brainsway Ltd. 19 Hartom Str. Jerusalem 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	QMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2020
Decision Date	04/16/2021
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