K240058
- 510(k) number
- K240058
- Device name
- AEYE-DS
- Applicant
- Aeye Health, Inc. NY · US
- Product code
- PIB — Diabetic Retinopathy Detection Device
- Decision date
- 2024-04-23
- Date received
- 2024-01-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K240058.pdf
Official FDA record: K240058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.