510(k) K082475 ยท DSI Detector And Alarm, Arrhythmia
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Nov 7, 2008 |
| Received | Aug 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082475
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.