QNV
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adjunctive Hemodynamic Indicator With Decision Point
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2220
- Medical specialty
- Cardiovascular
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AHI System (K221203) | Fifth Eye, Inc. | 2022-07-14 |
| AHI System (K212219) | Fifth Eye, Inc. | 2021-12-03 |
| Analytic for Hemodynamic Instability (AHI) (DEN200022) | Fifth Eye, Inc. | 2021-03-01 |
Track QNV automatically
Every clearance here is in the API, with alerts when new ones post.