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510(k) K203224

Device
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
Applicant
Edwards Lifesciences, LLC
510(k) number
K203224
Product code
QAQ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-30
Date received
2020-11-02
Regulation
870.2210
Classification name
Adjunctive Predictive Cardiovascular Indicator
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
DEN160044Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards Lifesciences, LLC2018-03-16

Legacy Summary#

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FDA Review#

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