510(k) K080612 ยท IZI System, X-Ray, Angiographic
LEICA FL800
| Applicant | Leica Microsystems (Schweiz) AG, Orange CA, US |
| Decision | Substantially Equivalent, May 9, 2008 |
| Received | Mar 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080612
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.