510(k) K801640 ยท DXY Implantable Pacemaker Pulse-Generator
SORIN PULSE GENERATOR, MODEL #LIT-214
| Applicant | Bentley Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 3, 1980 |
| Received | Jul 17, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801640
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.