510(k) K113594 ยท IZI System, X-Ray, Angiographic
C-THV SYSTEM
| Applicant | Paieon, Inc., Rosh Haayin, IL |
| Decision | Substantially Equivalent, Mar 2, 2012 |
| Received | Dec 5, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113594
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.