510(k) K894494 ยท DXY Implantable Pacemaker Pulse-Generator
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
| Applicant | Biotronik, GmbH & Co., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Oct 17, 1989 |
| Received | Jul 19, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894494
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.