FDA 510(k) Application Details - K210201

Device Classification Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder   More FDA Info for this Device
510(K) Number	K210201
Device Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant	Brainsway Ltd. 19 Hartom St. (Bynet Bldg) Har Hotzvim Jerusalem 9777518 IL Other 510(k) Applications for this Company
Contact	Ahava Stein Other 510(k) Applications for this Contact
Regulation Number	882.5805   More FDA Info for this Regulation Number
Classification Product Code	OBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2021
Decision Date	08/17/2021
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