510(k) K133481 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
| Applicant | St. Jude Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 28, 2014 |
| Received | Nov 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133481
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.