FDA.reportPublic FDA data

510(k) DEN160044

Device
Acumen Hypotension Prediction Index (HPI) Feature Software
Applicant
Edwards Lifesciences, LLC
510(k) number
DEN160044
Product code
QAQ
Decision
Unknown (DENG)
Decision date
2018-03-16
Date received
2016-09-26
Regulation
870.2210
Classification name
Adjunctive Predictive Cardiovascular Indicator
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Direct
Third party reviewed
N

Applicant Contact#

Contact
Lisa Gilman
Address
One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QAQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC2025-05-15
K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC2023-06-08
K203224Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences, LLC2021-07-30
K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - PressureEdwards Lifeciences, LLC2019-05-21