Panels › Cardiovascular › Product code QUO · Class 2
Adjunctive Heart Failure Status Indicator
Regulation 870.2200
1510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QUO
| Company | 510(k)s | Recalls |
|---|---|---|
| Ultromics Limited | 2 | 0 |
| Avicena, LLC | 1 | 0 |
| Icardio.Ai | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2025 | K251293 | CardioVision Icardio.Ai | QUO |
| Sep 23, 2024 | K240013 | EchoGo Heart Failure (2.0) Ultromics Limited, GB | QUO |
| Oct 6, 2023 | K223905 | Vivio® LVEDP System Avicena, LLC | QUO |
| Nov 23, 2022 | K222463 | EchoGo Heart Failure Ultromics Limited, GB | QUO |
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