510(k) DEN190029— Acumen Assisted Fluid Management (AFM) Software Feature

Unknown

Edwards Lifesciences

Clearance details

Applicant: Edwards Lifesciences
Product code: Code QMS
Advisory panel: Cardiovascular
Date received: 2019-06-03
Decision date: 2020-11-13
Decision: Unknown
Clearance type: Direct
Location: Irvine, CA, US

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