FDA Clearance

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

Submission
K183646
Type
510(k)
Company
Edwards Lifeciences, LLC
Decision Date
May 21, 2019
Specialty
Cardiovascular

Create a free account to keep reading

Free members get 10 full research views every month across publications, clinical trials, FDA clearances, adverse events, and NIH grants. No credit card required.

Want unlimited research access? See Pro plans

Data Accuracy Notice: Research intelligence on Health AI Central is aggregated from public sources (PubMed, ClinicalTrials.gov, FDA, NIH, CMS, and others) and refreshed nightly. Classifications and derived metrics are produced by automated methods described in our Methodology. We recommend verifying critical data points against the primary sources before making decisions.