FDA 510(k) Application Details - K082327

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K082327
Device Name	Oximeter, Tissue Saturation
Applicant	SOMANETICS CORP. 1653 EAST MAPLE RD. TROY, MI 48083-4208 US Other 510(k) Applications for this Company
Contact	RONALD A WIDMAN 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	08/14/2008
Decision Date	04/03/2009
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