510(k) K163021 ยท HKI Camera, Ophthalmic, Ac-Powered
HAAG-STREIT FUNDUS MODULE 300
| Applicant | Optomed OY, Oulu, FI |
| Decision | Substantially Equivalent, Apr 11, 2017 |
| Received | Oct 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163021
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.