K242116
- 510(k) number
- K242116
- Device name
- EyeBOX EBX-4.1
- Applicant
- Oculogica, Inc. WI · US
- Product code
- QEA — Brain Injury Adjunctive Interpretive Oculomotor Asse
- Decision date
- 2025-04-04
- Date received
- 2024-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242116.pdf
Official FDA record: K242116
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.