510(k) K831633 ยท DXY Implantable Pacemaker Pulse-Generator
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR
| Applicant | Intermedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 12, 1983 |
| Received | May 20, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831633
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.