510(k) K183683 ยท FDA Enteroscope And Accessories
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
| Applicant | Fujifilm Corporation, Ashigara Kami-Gun, JP |
| Decision | Substantially Equivalent, Feb 27, 2019 |
| Received | Dec 28, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183683
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.