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Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

FDA product code QEA · Class 2 · Neurology

2
Registered devices
0
Adverse events
2
Recalls
7
510(k) clearances

Devices with this code

EyeBOX — Oculogica Inc.EYE-SYNC — NEUROSYNC INC.

Recent recalls

DateFirmReason
2023-09-19NeuroSync, Inc.Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in
2019-04-16OCULOGICAA review of the user manual revealed that two precaution statements were missing.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.