Panels › Cardiovascular › Product code SAT · Class 2
Pulmonary Hypertension Machine Learning-Based Notification Software
Regulation 870.2380
2510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SAT
| Company | 510(k)s | Recalls |
|---|---|---|
| Analytics For Life, Inc. | 1 | 0 |
| Anumana, Inc. | 1 | 0 |
| Tempus AI, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2026 | K253699 | Tempus ECG-PH Tempus AI, Inc. | SAT |
| Mar 28, 2026 | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) Anumana, Inc. | SAT |
| Apr 5, 2024 | K233666 | CorVista System with PH Add-On Analytics For Life, Inc., CA | SAT |
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