510(k) K252360 ยท SAT Pulmonary Hypertension Machine Learning-Based Notification Software
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
| Applicant | Anumana, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Mar 28, 2026 |
| Received | Jul 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252360
No recall in the FDA data names this 510(k).
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