510(k) K083828 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT
| Applicant | Transoma, St. Paul MN, US |
| Decision | Substantially Equivalent, Feb 11, 2009 |
| Received | Dec 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083828
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.