510(k) K202097 ยท HKI Camera, Ophthalmic, Ac-Powered
Fundus Camera
| Applicant | Huvitz Co., Ltd., Anyang-Si, KR |
| Decision | Substantially Equivalent, Feb 2, 2021 |
| Received | Jul 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202097
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.