510(k) K250119 ยท QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Tempus ECG-Low EF
| Applicant | Tempus AI, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Jul 15, 2025 |
| Received | Jan 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250119
No recall in the FDA data names this 510(k).
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