510(k) K122090 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
| Applicant | St. Jude Medical, Cardiac Rhythm Management Divisi, Sylmar CA, US |
| Decision | Substantially Equivalent, Nov 15, 2012 |
| Received | Jul 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122090
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.