FDA 510(k) Application Details - K242518

Device Classification Name	More FDA Info for this Device
510(K) Number	K242518
Device Name	Hypertension Prediction Index (HePI) Algorithm
Applicant	Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Daphney Germain-Kolawole Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2024
Decision Date	05/15/2025
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