510(k) K221183 ยท PIB Diabetic Retinopathy Detection Device
AEYE-DS
| Applicant | Aeye Health, Inc., New York NY, US |
| Decision | Substantially Equivalent, Nov 10, 2022 |
| Received | Apr 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221183
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.