510(k) K200833 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
RX-1 Rhythm Express Remote Cardiac Monitoring System
| Applicant | VivaQuant, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Sep 2, 2020 |
| Received | Mar 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200833
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.