510(k) K180378 ยท HKI Camera, Ophthalmic, Ac-Powered
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
| Applicant | Optomed OY, Oulu, FI |
| Decision | Substantially Equivalent, Apr 5, 2018 |
| Received | Feb 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180378
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.