510(k) K161727 ยท HKI Camera, Ophthalmic, Ac-Powered
Eyenez Ophthalmic Camera
| Applicant | Eyenez, LLC, Pasadena CA, US |
| Decision | Substantially Equivalent, Oct 4, 2016 |
| Received | Jun 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161727
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.