K183646

Substantially Equivalent

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

Applicant: Edwards Lifeciences, LLC
Product code: QAQ
Advisory panel: Cardiovascular
Date received: 2018-12-26
Decision date: 2019-05-21
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.