510(k) K230292 ยท QDA Electrocardiograph Software For Over-The-Counter Use
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
| Applicant | Samsung Electronics Co., Ltd., Suwon-Si, KR |
| Decision | Substantially Equivalent, May 2, 2023 |
| Received | Feb 2, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230292
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.