FDA Product Code
FDA Product Code QNV — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2220
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221203 | AHI System | Fifth Eye, Inc. | 2022-07-14 | Special | PDF ↗ |
| K212219 | AHI System | Fifth Eye, Inc. | 2021-12-03 | Traditional | PDF ↗ |
| DEN200022 | Analytic for Hemodynamic Instability (AHI) | Fifth Eye, Inc. | 2021-03-01 | Direct | — |
Product code QNV · Class II · Cardiovascular. Data: openFDA.