FDA 510(k) Application Details - K171245

Device Classification Name	Oximeter, Tissue Saturation   More FDA Info for this Device
510(K) Number	K171245
Device Name	Oximeter, Tissue Saturation
Applicant	Christie Medical Holdings, Inc. 3175 Lenox Park Boulevard, Suite 200 Memphis, TN 38115 US Other 510(k) Applications for this Company
Contact	Salwa Rezk 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	04/28/2017
Decision Date	08/09/2018
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