QMS — Adjunctive Open Loop Fluid Therapy Recommender Class II
FDA product code QMS covers "Adjunctive Open Loop Fluid Therapy Recommender", a Class II medical device regulated under 21 CFR 870.5600. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.