510(k) K853057 ยท DXY Implantable Pacemaker Pulse-Generator
TRIOS - M
| Applicant | Biotronik Sales, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Sep 12, 1985 |
| Received | Jul 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853057
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.