510(k) K994240 ยท DTB Permanent Pacemaker Electrode
EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Apr 13, 2000 |
| Received | Dec 16, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994240
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.