Panels › Cardiovascular › Product code SBQ · Class 2
Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
Regulation 870.2380
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SBQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Tempus AI, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2026 | K254297 | Tempus ECG-MR Tempus AI, Inc. | SBQ |
| Jun 21, 2024 | K233549 | Tempus ECG-AF Tempus AI, Inc. | SBQ |
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