FDA 510(k) Application Details - K163472

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K163472
Device Name	Oximeter, Tissue Saturation
Applicant	VIOPTIX, INC. 39655 EUREKA DRIVE NEWARK, CA 94560 US Other 510(k) Applications for this Company
Contact	MARK LONSINGER Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	MUD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2016
Decision Date	11/16/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review