510(k) K083745 ยท IZI System, X-Ray, Angiographic
THE IC-PRO SYSTEM, MODEL VERSION 3.2
| Applicant | Paieon, Inc., Rosh Haayin, IL |
| Decision | Substantially Equivalent, Feb 17, 2009 |
| Received | Dec 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083745
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.