510(k) K221774 ยท QDA Electrocardiograph Software For Over-The-Counter Use
Garmin ECG App
| Applicant | Garmin International, Inc., Olathe KS, US |
| Decision | Substantially Equivalent, Jan 12, 2023 |
| Received | Jun 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221774
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.