K243664
- 510(k) number
- K243664
- Device name
- Sentinel Camera
- Applicant
- Ai Optics NY · US
- Product code
- HKI — Camera, Ophthalmic, Ac-Powered
- Decision date
- 2024-12-17
- Date received
- 2024-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243664.pdf
Official FDA record: K243664
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.