510(k) K190825 ยท DTE Pulse-Generator, Pacemaker, External
Medtronic Model 5392 External Pulse Generator (EPG)
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Apr 30, 2019 |
| Received | Apr 1, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190825
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.