510(k) K820853 ยท DXY Implantable Pacemaker Pulse-Generator
QUANTUM MODELS 253-09, 254-09 254-10
| Applicant | Intermedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 9, 1982 |
| Received | Mar 26, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820853
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.