510(k) K240058 ยท PIB Diabetic Retinopathy Detection Device
AEYE-DS
| Applicant | Aeye Health, Inc., New York NY, US |
| Decision | Substantially Equivalent, Apr 23, 2024 |
| Received | Jan 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240058
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.