510(k) K861543 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
CARDIOMAX-II
| Applicant | Columbus Instruments Intl. Corp., Columbus OH, US |
| Decision | Substantially Equivalent, Mar 10, 1987 |
| Received | Apr 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861543
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.