Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an AI-enabled medical device from Samsung Electronics Co., Ltd, listed by FDA (510(k), K230292) with a decision date of 2023-05-02. Review panel: Cardiovascular.
| FDA submission number | K230292 |
|---|---|
| Pathway | 510(k) |
| Company | Samsung Electronics Co., Ltd |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2023-05-02 |
| Decision | Substantially Equivalent |
| Product code | QDA |
| Classification | Electrocardiograph Software For Over-The-Counter Use |
| Device class | 2 |
| Regulation number | 870.2345 |
| Review time (calendar days) | 89 |
| Applicant country | KR |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.