510(k) K842105 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
RIGHT VENTRICULAR EJECTION FRACTION-
| Applicant | American Edwards Laboratories, Santa Ana CA, US |
| Decision | Substantially Equivalent, Jan 15, 1985 |
| Received | May 25, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842105
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.