510(k) K083674 ยท DTC Analyzer, Pacemaker Generator Function
PK-141 PATIENT CABLE
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Apr 1, 2009 |
| Received | Dec 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083674
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.