510(k) K150221 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
EPX-4440HD and EPX-4400HD with FICE
| Applicant | Fujifilm Medical System U.S.A., Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Oct 1, 2015 |
| Received | Jan 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150221
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.