QMS

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Adjunctive Open Loop Fluid Therapy Recommender

Device class

Class II (moderate risk)

Regulation

21 CFR 870.5600

Medical specialty

Cardiovascular

Flags

Third-party review eligible

FDA 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.

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