510(k) K143556 ยท FDA Enteroscope And Accessories
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Aug 20, 2015 |
| Received | Dec 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143556
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.