FDA 510(k) Application Details - K233984

Device Classification Name	More FDA Info for this Device
510(K) Number	K233984
Device Name	Acumen Assisted Fluid Management (AFM) Software Feature
Applicant	Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Kshama Pai Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QMS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2023
Decision Date	08/02/2024
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