510(k) K190295 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Confirm Rx Insertable Cardiac Monitor
| Applicant | Abbott (St. Jude Medical), Sylmar CA, US |
| Decision | Substantially Equivalent, Apr 10, 2019 |
| Received | Feb 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190295
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.