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510(k) DEN190029

Acumen Assisted Fluid Management (AFM) Software Feature by Edwards Lifesciences — Product Code QMS

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 13, 2020
Date Received
June 3, 2019
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adjunctive Open Loop Fluid Therapy Recommender
Device Class
Class II
Regulation Number
870.5600
Review Panel
CV
Submission Type

The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patient’s estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

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Other clearances for product code QMS

  • K233984 — Acumen Assisted Fluid Management (AFM) Software Feature (August 2, 2024)