FDA 510(k) Application Details - K141234

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K141234
Device Name	Oximeter, Tissue Saturation
Applicant	VIOPTIX, INC. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND 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	05/13/2014
Decision Date	07/01/2014
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