510(k) K140295 ยท FDS Gastroscope And Accessories, Flexible/Rigid
GIS ENDOSCOPIC OPTICAL LENS
| Applicant | Gi Scientific, LLC, Newbury NH, US |
| Decision | Substantially Equivalent, Jul 24, 2014 |
| Received | Feb 6, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140295
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.