510(k) K011098 ยท MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
| Applicant | Medtronic Vascular, Minneapolis MN, US |
| Decision | Substantially Equivalent, May 4, 2001 |
| Received | Apr 11, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011098
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.