510(k) K964190 ยท DTE Pulse-Generator, Pacemaker, External
ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Jul 10, 1997 |
| Received | Oct 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964190
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.