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Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

FDA product code QEA · 6 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1455
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-07-31 – 2026-06-05

A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.

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