510(k) DEN250044 ยท SHS
Queen of Hearts (ACS AI ECG Model)
| Applicant | Powerful Medical, Inc., New York NY, US |
| Decision | Unknown, Sep 3, 2026 |
| Received | Sep 22, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250044
No recall in the FDA data names this 510(k).
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