510(k) K183704 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
RX-1 Rhythm Express Remote Cardiac Monitoring System
| Applicant | VivaQuant, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Feb 16, 2019 |
| Received | Dec 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183704
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.