510(k) K191183
- Device
- EyeBOX
- Applicant
- Oculogica, Inc.
- 510(k) number
- K191183
- Product code
- QEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-31
- Date received
- 2019-05-02
- Regulation
- 882.1455
- Classification name
- Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rosina Samadani
- Address
- 33 Irving Pl. New York NY US 10003 10003
FDA Registration Numbers#
- 3014535677
- 3014133165
Source Documents#
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 |
| DEN170091 | EyeBOX | Oculogica, Inc. | 2018-12-28 |
Legacy Summary#
summary
FDA Review#
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