510(k) K042708 ยท DTE Pulse-Generator, Pacemaker, External
ERA 3000 PACING SYSTEM ANALYZER
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Oct 20, 2004 |
| Received | Sep 30, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042708
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.