510(k) K122012 ยท OZT Balloon Aortic Valvuloplasty
Z-MED Z-MED II
| Applicant | NuMED, Inc., Hopkinton NY, US |
| Decision | Substantially Equivalent, Oct 4, 2012 |
| Received | Jul 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122012
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.