510(k) K200254 ยท HKI Camera, Ophthalmic, Ac-Powered
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
| Applicant | Optina Diagnostics, Montreal, CA |
| Decision | Substantially Equivalent, Apr 27, 2020 |
| Received | Feb 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200254
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.