510(k) K180285 ยท FDF Colonoscope And Accessories, Flexible/Rigid
PENTAX Medical Video Colonoscope EC34-i10T Series
| Applicant | Pentax Medical of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Oct 26, 2018 |
| Received | Feb 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180285
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.