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Adjunctive Open Loop Fluid Therapy Recommender

FDA product code QMS · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.5600
Review panel
CV
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2024-08-02 – 2024-08-02

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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