510(k) K180414 ยท FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
EPX-4440FN Digital Video Processor with Light Source
| Applicant | Fujifilm New Development U.S.A., Inc., Waltham MA, US |
| Decision | Substantially Equivalent, May 24, 2018 |
| Received | Feb 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180414
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.