510(k) K063035 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
SLEUTH IMPLANTABLE ECG MONITORING SYSTEM
| Applicant | Transnoma Medical, Inc., Arden Hills MN, US |
| Decision | Substantially Equivalent, Oct 1, 2007 |
| Received | Sep 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063035
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.