510(k) K103764 ยท DSI Detector And Alarm, Arrhythmia
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, May 4, 2011 |
| Received | Dec 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103764
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.