FDA 510(k) Application Details - K180881

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K180881
Device Name	Computer, Diagnostic, Programmable
Applicant	Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Chirag Shah Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2018
Decision Date	11/16/2018
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