510(k) K071641 ยท DSI Detector And Alarm, Arrhythmia
REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Nov 21, 2007 |
| Received | Jun 15, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071641
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.