DEN170091 is an FDA 510(k) submission for the EyeBOX. This device is classified as a Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid (Class II - Special Controls, product code QEA).
Submitted by Oculogica, Inc. (New York, US). The FDA issued a Not Cleared (DENG) decision on December 28, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1455. A Traumatic Brain Injury Eye Movement Assessment Aid Is A Prescription Device That Uses A Patients Tracked Eye Movements To Provide An Interpretation Of The Functional Condition Of The Patients Brain. This Device Is An Assessment Aid That Is Not Intended For Standalone Detection Or Diagnostic Purposes..
| 510(k) Number | DEN170091 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 22, 2017 |
| Decision Date | December 28, 2018 |
| Days to Decision | 371 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QEA - Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1455 |
| Definition | A Traumatic Brain Injury Eye Movement Assessment Aid Is A Prescription Device That Uses A Patients Tracked Eye Movements To Provide An Interpretation Of The Functional Condition Of The Patients Brain. This Device Is An Assessment Aid That Is Not Intended For Standalone Detection Or Diagnostic Purposes. |