510(k) K182040 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
Coala Heart Monitor
| Applicant | Coala Life AB, Stockholm, SE |
| Decision | Substantially Equivalent, Feb 8, 2019 |
| Received | Jul 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182040
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.