510(k) K212163 ยท DPS Electrocardiograph
Coala Heart Monitor
| Applicant | Coala Life AB, Uppsala, SE |
| Decision | Substantially Equivalent, Apr 14, 2022 |
| Received | Jul 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212163
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.