510(k) K181522 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Jul 9, 2018 |
| Received | Jun 11, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181522
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.