510(k) K182199 ยท HKI Camera, Ophthalmic, Ac-Powered
NFC-700 non-mydriatic auto fundus camera
| Applicant | Crystalvue Medical Corporation, Taoyuan City, TW |
| Decision | Substantially Equivalent, Jan 2, 2019 |
| Received | Aug 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182199
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.