510(k) K984058 ยท IZQ Injector, Contrast Medium, Automatic
ACIST INJECTOR SYSTEM, MODEL CL100 H
| Applicant | Acist Medical Systems, Eden Prairie MN, US |
| Decision | Substantially Equivalent, Feb 11, 1999 |
| Received | Nov 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984058
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.