510(k) K802316 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
PDS THERMAL DILUTION CARDIAC MODULE(OUT)
| Applicant | General Electric Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 26, 1980 |
| Received | Sep 23, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802316
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.