EyeBOX (Model EBX-4)— 510(k) K212310
Substantially EquivalentOculogica, Inc.
FDA 510(k) clearance K212310 for EyeBOX (Model EBX-4), Substantially Equivalent on 2021-12-22. Applicant: Oculogica, Inc.. Device class: 2.
Clearance details
- Applicant
- Oculogica, Inc.
- Product code
- Code QEA
- Device class
- Class 2
- Regulation
- 21 CFR 882.1455
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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