510(k) K172801 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
ECG SENTINEL System
| Applicant | Cardiomedix, Inc., Evanston IL, US |
| Decision | Substantially Equivalent, Oct 18, 2017 |
| Received | Sep 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172801
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.