510(k) K082907 ยท IZI System, X-Ray, Angiographic
IC-PRO SYSTEM, VERSION 3.1.0.4
| Applicant | Paieon, Inc., Rosh Haayin, IL |
| Decision | Substantially Equivalent, Nov 18, 2008 |
| Received | Sep 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082907
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.