510(k) K232699 ยท QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
Low Ejection Fraction AI-ECG Algorithm
| Applicant | Anumana, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Sep 28, 2023 |
| Received | Sep 5, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232699
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