510(k) K223357 ยท PIB Diabetic Retinopathy Detection Device
EyeArt v2.2.0
| Applicant | Eyenuk, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jun 16, 2023 |
| Received | Nov 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223357
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.