510(k) K250770 ยท HKI Camera, Ophthalmic, Ac-Powered
Optina-4C (MHRC-C1N)
| Applicant | Optina Diagnostics, Inc., Montreal, CA |
| Decision | Substantially Equivalent, Sep 4, 2025 |
| Received | Mar 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250770
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.