510(k) K073328 ยท IZI System, X-Ray, Angiographic
CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
| Applicant | Paieon, Inc., Rosh Haayin, IL |
| Decision | Substantially Equivalent, Sep 9, 2008 |
| Received | Nov 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073328
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.