510(k) K122161 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
SJM CONFIRM
| Applicant | St Jude Medical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 28, 2012 |
| Received | Jul 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122161
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.