510(k) K163614 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
PENTAX Medical ED34-i10T, Video Duodenoscope
| Applicant | Pentax Medical, Montvale NJ, US |
| Decision | Substantially Equivalent, Sep 20, 2017 |
| Received | Dec 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163614
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.