FDA 510(k) Application Details - K213682

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K213682
Device Name	Computer, Diagnostic, Programmable
Applicant	Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Manthan Damani 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	11/22/2021
Decision Date	06/22/2022
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