Acumen Hypotension Prediction Index (HPI) Feature Software— 510(k) DEN160044

Unknown

Edwards Lifesciences, LLC

FDA 510(k) clearance DEN160044 for Acumen Hypotension Prediction Index (HPI) Feature Software, Unknown on 2018-03-16. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code QAQ
Advisory panel: Cardiovascular
Date received: 2016-09-26
Decision date: 2018-03-16
Decision: Unknown
Clearance type: Direct
Location: Irvine, CA, US

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