FDA 510(k) Application Details - K113507

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K113507
Device Name	Oximeter, Tissue Saturation
Applicant	KENT IMAGING INC. 1440, 720- 13TH AVENUE SW CALGARY T2R 1M5 CA Other 510(k) Applications for this Company
Contact	DARRELL BARNHART 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	11/28/2011
Decision Date	08/08/2012
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