510(k) K010281 ยท DTB Permanent Pacemaker Electrode
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Apr 9, 2002 |
| Received | Jan 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010281
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.