FDA 510(k) Application Details - K202537

Device Classification Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder   More FDA Info for this Device
510(K) Number	K202537
Device Name	Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant	REMED Co., Ltd #301-#303 Migun Techno World II, 187, Techno 2-Ro Yuseong-gu Daejeon 34025 KR Other 510(k) Applications for this Company
Contact	Yonsoo Nam 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	09/01/2020
Decision Date	11/26/2021
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