510(k) K190954 ยท HKI Camera, Ophthalmic, Ac-Powered
Fundus Camera
| Applicant | Chongqing Bio Newvision Medical Equipment , Ltd., Chongqing, CN |
| Decision | Substantially Equivalent, Jan 22, 2020 |
| Received | Apr 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190954
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.