QMS — Adjunctive Open Loop Fluid Therapy Recommender Class II
Classification Details
- Product Code
- QMS
- Device Class
- Class II
- Regulation Number
- 870.5600
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patients 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.