The following data is part of a De Novo classification by Oculogica, Inc. with the FDA for Eyebox.
| DeNovo ID | DEN170091 |
| Device Name: | EyeBOX |
| Classification | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Applicant | Oculogica, Inc. 33 Irving Place New York, NY 10003 |
| Contact | Rosina Samadani |
| Product Code | QEA |
| CFR Regulation Number | 882.1455 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2017-12-22 |
| Decision Date | 2018-12-28 |
| Reclassification Order: | Reclassification Order |