510(k) K980869 ยท DTB Permanent Pacemaker Electrode
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Sep 10, 1998 |
| Received | Mar 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980869
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.