FDA Product Code
FDA Product Code QEA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1455
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254086 | EyeBOX SNAP | Oculogica, Inc. | 2026-06-05 | Traditional | PDF ↗ |
| K242116 | EyeBOX EBX-4.1 | Oculogica, Inc. | 2025-04-04 | Traditional | PDF ↗ |
| K212310 | EyeBOX (Model EBX-4) | Oculogica, Inc. | 2021-12-22 | Traditional | PDF ↗ |
| K202927 | EYE-SYNC | Syncthink, Inc. | 2021-10-02 | Traditional | PDF ↗ |
| K201841 | EyeBOX | Oculogica, Inc. | 2020-09-06 | Traditional | PDF ↗ |
| K191183 | EyeBOX | Oculogica, Inc. | 2019-07-31 | Traditional | PDF ↗ |
| DEN170091 | EyeBOX | Oculogica, Inc. | 2018-12-28 | Direct | — |
Product code QEA · Class II · Neurology. Data: openFDA.