510(k) K233549 ยท SBQ Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
Tempus ECG-AF
| Applicant | Tempus AI, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Jun 21, 2024 |
| Received | Nov 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233549
No recall in the FDA data names this 510(k).
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