QNVClass II
Adjunctive Hemodynamic Indicator With Decision Point
21 CFR 870.2220 / Cardiovascular
QNV is the FDA product code for Adjunctive Hemodynamic Indicator With Decision Point, a class II device type, regulated under 21 CFR 870.2220. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QNV
- Device name
- Adjunctive Hemodynamic Indicator With Decision Point
- 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.
- Regulation
- 21 CFR 870.2220
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code QNV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 2 |
| 2022 | 1 |
Applicants with the most clearances
Product code QNV| Applicant | Clearances |
|---|---|
| Fifth Eye, Inc. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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