510(k) K192593 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Confirm Rx Insertable Cardiac Monitor
| Applicant | Abbott, Sylmar CA, US |
| Decision | Substantially Equivalent, Oct 18, 2019 |
| Received | Sep 20, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192593
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.