510(k) K801055 ยท DTE Pulse-Generator, Pacemaker, External
COMPUPACE, 524-01 PACER SYSTEM COMPUTER
| Applicant | Intermedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 31, 1980 |
| Received | May 6, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801055
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.