FDA 510(k) Application Details - K161663

Device Classification Name	More FDA Info for this Device
510(K) Number	K161663
Device Name	sTMS mini
Applicant	ENEURA INC 715 NORTH PASTORIA AVENUE SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	CYNTHIA MERRELL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2016
Decision Date	08/23/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review