510(k) K181310 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
| Applicant | Cardiocomm Solutions, Inc., North York, CA |
| Decision | Substantially Equivalent, Feb 22, 2019 |
| Received | May 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181310
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.