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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adjunctive open loop fluid therapy recommender
Regulation Description Adjunctive open loop fluid therapy recommender.
Definition 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.
Product CodeQMS
Regulation Number 870.5600
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1

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