510(k) DEN170091
- Device
- EyeBOX
- Applicant
- Oculogica, Inc.
- 510(k) number
- DEN170091
- Product code
- QEA
- Decision
- Unknown (DENG)
- Decision date
- 2018-12-28
- Date received
- 2017-12-22
- Regulation
- 882.1455
- Classification name
- Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Rosina Samadani
- Address
- 33 Irving Pl. New York NY US 10003 10003
FDA Registration Numbers#
- 3014535677
- 3014133165
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QEA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254086 | EyeBOX SNAP | Oculogica, Inc. | 2026-06-05 |
| K242116 | EyeBOX EBX-4.1 | Oculogica, Inc. | 2025-04-04 |
| K212310 | EyeBOX (Model EBX-4) | Oculogica, Inc. | 2021-12-22 |
| K202927 | EYE-SYNC | Syncthink, Inc. | 2021-10-02 |
| K201841 | EyeBOX | Oculogica, Inc. | 2020-09-06 |
| K191183 | EyeBOX | Oculogica, Inc. | 2019-07-31 |