QNV — Adjunctive Hemodynamic Indicator With Decision Point Class II
FDA product code QNV covers "Adjunctive Hemodynamic Indicator With Decision Point", a Class II medical device regulated under 21 CFR 870.2220. Submissions are reviewed by the Cardiovascular panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QNV
- Device Class
- Class II
- Regulation Number
- 870.2220
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.