FDA Product Code
FDA Product Code QUO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2200
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251293 | CardioVision | Icardio.Ai | 2025-11-21 | Traditional | PDF ↗ |
| K240013 | EchoGo Heart Failure (2.0) | Ultromics Limited | 2024-09-23 | Traditional | PDF ↗ |
| K223905 | Vivio® LVEDP System | Avicena, LLC | 2023-10-06 | Traditional | PDF ↗ |
| K222463 | EchoGo Heart Failure | Ultromics Limited | 2022-11-23 | Traditional | PDF ↗ |
Product code QUO · Class II · Cardiovascular. Data: openFDA.