510(k) K161791 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Aer-O-Scope Colonoscope System
| Applicant | Gi View , Ltd., Ramat Gan, IL |
| Decision | Substantially Equivalent, Aug 11, 2016 |
| Received | Jun 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161791
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.