EyeBOX EBX-4.1— 510(k) K242116

Substantially Equivalent

Oculogica, Inc.

FDA 510(k) clearance K242116 for EyeBOX EBX-4.1, Substantially Equivalent on 2025-04-04. 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 Richmond, WI, US
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