The following data is part of a premarket notification filed by Oculogica, Inc. with the FDA for Eyebox (model Ebx-4).
| Device ID | K212310 |
| 510k Number | K212310 |
| Device Name: | EyeBOX (Model EBX-4) |
| Classification | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Applicant | Oculogica, Inc. 33 Irving Place New York, NY 10003 |
| Contact | Rosina Samadani |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | QEA |
| CFR Regulation Number | 882.1455 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-23 |
| Decision Date | 2021-12-22 |