510(k) K001413 ยท DTB Permanent Pacemaker Electrode
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jun 2, 2000 |
| Received | May 4, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001413
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.