FDA 510(k) Application Details - K160645

Device Classification Name	Catheter, Oximeter, Fiberoptic   More FDA Info for this Device
510(K) Number	K160645
Device Name	Catheter, Oximeter, Fiberoptic
Applicant	EDWARDS LIFESCIENCES, LLC 1 EDWARDS WAY IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	Deana Boushell Other 510(k) Applications for this Contact
Regulation Number	870.1230   More FDA Info for this Regulation Number
Classification Product Code	DQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2016
Decision Date	06/16/2016
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