510(k) K220158 ยท FDF Colonoscope And Accessories, Flexible/Rigid
G-EYE System
| Applicant | Smart Medical Systems , Ltd., Ra'Anana, IL |
| Decision | Substantially Equivalent, Apr 11, 2022 |
| Received | Jan 19, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220158
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.