510(k) K133434 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GENESIS II
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Nov 26, 2014 |
| Received | Nov 8, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133434
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.