FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EyeBOX
K Number: DEN170091
·
Decision Dec 28, 2018
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
6
Applicant Total
6
Review Days
371
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Basic Information
- Device Name
- EyeBOX
- K Number
- DEN170091
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.1455
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Oculogica, Inc.
- Date Received
- December 22, 2017
- Decision Date
- December 28, 2018
- Product Code
- QEA
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QEA | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | FDA class 2 | Neurology |
Similar 510(k) Clearances
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Other Clearances by Oculogica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254086 | EyeBOX SNAP | Jun 5, 2026 | Substantially Equivalent |
| K242116 | EyeBOX EBX-4.1 | Apr 4, 2025 | Substantially Equivalent |
| K212310 | EyeBOX (Model EBX-4) | Dec 22, 2021 | Substantially Equivalent |
| K201841 | EyeBOX | Sep 6, 2020 | Substantially Equivalent |
| K191183 | EyeBOX | Jul 31, 2019 | Substantially Equivalent |