K203224

Substantially Equivalent

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

Applicant: Edwards Lifesciences, LLC
Product code: QAQ
Advisory panel: Cardiovascular
Date received: 2020-11-02
Decision date: 2021-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.