510(k) K192588 ยท FDF Colonoscope And Accessories, Flexible/Rigid
G-EYE System
| Applicant | Smart Medical Systems , Ltd., Ra'Anana, IL |
| Decision | Substantially Equivalent, Apr 15, 2020 |
| Received | Sep 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192588
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.