Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

Edwards Lifeciences, LLC · K183646 · 2019-05-21

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure is an AI-enabled medical device from Edwards Lifeciences, LLC, listed by FDA (510(k), K183646) with a decision date of 2019-05-21. Review panel: Cardiovascular.

FDA submission numberK183646
Pathway510(k)
CompanyEdwards Lifeciences, LLC
Review panel (specialty)Cardiovascular
FDA decision date2019-05-21
DecisionSubstantially Equivalent
Product codeQAQ
ClassificationAdjunctive Predictive Cardiovascular Indicator
Device class2
Regulation number870.2210
Review time (calendar days)146
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

All Cardiovascular AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.