510(k) K210197 ยท HKI Camera, Ophthalmic, Ac-Powered
NFC-600 Automated Portable Retinal Camera
| Applicant | Crystalvue Medical Corporation, Taoyuan City, TW |
| Decision | Substantially Equivalent, Apr 13, 2021 |
| Received | Jan 25, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210197
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.