510(k) K250649 ยท QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Bunkerhill ECG-EF
| Applicant | BunkerHill Health, San Francisco CA, US |
| Decision | Substantially Equivalent, Sep 19, 2025 |
| Received | Mar 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250649
No recall in the FDA data names this 510(k).
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