FDA 510(k) Application Details - DEN160044

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160044
Device Name	Acumen Hypotension Prediction Index (HPI) Feature Software
Applicant	Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Lisa Gilman 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	09/26/2016
Decision Date	03/16/2018
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review