510(k) K853194 ยท DTE Pulse-Generator, Pacemaker, External
ERA-20
| Applicant | Biotronik Sales, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Mar 11, 1987 |
| Received | Jul 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853194
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.