510(k) K101968 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
| Applicant | St Jude Medical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 15, 2010 |
| Received | Jul 12, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101968
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.