510(k) K973368 ยท IZI System, X-Ray, Angiographic
STRAIT'MAP OPTION
| Applicant | Ge Medical Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Oct 17, 1997 |
| Received | Sep 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973368
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.