510(k) K250683 ยท HKI Camera, Ophthalmic, Ac-Powered
Resolve Fundus Camera
| Applicant | Optain Health, Inc., New York NY, US |
| Decision | Substantially Equivalent, Apr 30, 2025 |
| Received | Mar 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250683
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.