510(k) K192280 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
PENTAX Medical ED-3490TK Video Duodenoscope
| Applicant | Pentax Medical, Montvale NJ, US |
| Decision | Substantially Equivalent, Oct 21, 2019 |
| Received | Aug 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192280
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.