510(k) K851365 ยท DXY Implantable Pacemaker Pulse-Generator
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
| Applicant | Sorin Biomedica, Fiat, USA, Inc., New York NY, US |
| Decision | Substantially Equivalent, Dec 3, 1985 |
| Received | Apr 5, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851365
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.