510(k) K161828 · LLZ System, Image Processing, Radiological
kneeEOS
| Applicant | Onefit Medical, Besançon, FR |
| Decision | Substantially Equivalent, Oct 3, 2016 |
| Received | Jul 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161828
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.