FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EyeBOX
K Number: K191183
·
Decision Jul 31, 2019
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
6
Applicant Total
6
Review Days
90
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Basic Information
- Device Name
- EyeBOX
- K Number
- K191183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1455
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oculogica, Inc.
- Date Received
- May 2, 2019
- Decision Date
- July 31, 2019
- 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 |
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