510(k) K130003 ยท IZI System, X-Ray, Angiographic
XIRALITE FLOURESCENCE IMAGING SYSTEM X4
| Applicant | Mivenion GmbH, Berlin, DE |
| Decision | Substantially Equivalent, Jan 31, 2014 |
| Received | Jan 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130003
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.