510(k) K193296 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
eCordum Cardiac Monitor (eCordum CM)
| Applicant | Ecordum, Inc., East Northport NY, US |
| Decision | Substantially Equivalent, Oct 30, 2020 |
| Received | Nov 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193296
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.