510(k) K201841
K201841 is an FDA 510(k) premarket notification submitted by Oculogica, Inc. for the device "EyeBOX". The FDA issued a decision of Substantially Equivalent on September 6, 2020. The device falls under product code QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid), a Class II device regulated under 21 CFR 882.1455. Oculogica, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2020
- Date Received
- July 2, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.1455
- Review Panel
- NE
- Submission Type
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.