510(k) K081365 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
| Applicant | St Jude Medical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 15, 2008 |
| Received | May 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2011 | St Jude Medical CRMD SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE).
This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing i Terminated |
MXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.