510(k) K091206 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
| Applicant | Transoma Medical, St. Paul MN, US |
| Decision | Substantially Equivalent, May 18, 2009 |
| Received | Apr 24, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091206
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.