510(k) K181537 ยท IZI System, X-Ray, Angiographic
GLOW800
| Applicant | Leica Microsystems (Schweiz) AG, Heerbrugg, CH |
| Decision | Substantially Equivalent, Sep 7, 2018 |
| Received | Jun 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181537
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.