510(k) K872529 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
| Applicant | American Edwards Laboratories, Santa Ana CA, US |
| Decision | Substantially Equivalent, Sep 15, 1987 |
| Received | Jun 26, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872529
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.