FDA 510(k) Application Details - K161237

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K161237
Device Name	Oximeter, Tissue Saturation
Applicant	HYPERMED IMAGING, INC. 8700 TRAIL LAKE DR WEST, SUITE 200 MEMPHIS, TN 38125 US Other 510(k) Applications for this Company
Contact	Carlyn Reynolds 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	05/02/2016
Decision Date	12/16/2016
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