FDA product code QMS

Adjunctive Open Loop Fluid Therapy Recommender

Cardiovascular·Class 2·21 CFR 870.5600
US regulatory classifications
US Product Code (FDA)
QMS
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.5600
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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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About this record

Adjunctive Open Loop Fluid Therapy Recommender is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.