EyeBOX— 510(k) K191183

Substantially Equivalent

Oculogica, Inc.

FDA 510(k) clearance K191183 for EyeBOX, Substantially Equivalent on 2019-07-31. 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: 2019-05-02
Decision date: 2019-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.