510(k) K201325 ยท HKI Camera, Ophthalmic, Ac-Powered
Optomed Smartscope M5 with Optomed Smartscope FA
| Applicant | Optomed Oyj, Oulu, FI |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | May 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201325
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.