510(k) K073147 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
| Applicant | Transoma Medical, Arden Hills MN, US |
| Decision | Substantially Equivalent, Dec 3, 2007 |
| Received | Nov 8, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073147
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.