510(k) K162550 ยท DTE Pulse-Generator, Pacemaker, External
Medtronic Model 5392 External Pulse Generator (EPG)
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Oct 12, 2016 |
| Received | Sep 13, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162550
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.