EyeBOX

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Oculogica, Inc.

The following data is part of a premarket notification filed by Oculogica, Inc. with the FDA for Eyebox.

Pre-market Notification Details

• Device ID: K191183
• 510k Number: K191183
• Device Name: EyeBOX
• Classification: Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
• Applicant: Oculogica, Inc. 33 Irving Place New York, NY 10003
• Contact: Rosina Samadani
• Correspondent: Rosina Samadani; Oculogica, Inc. 33 Irving Place New York, NY 10003
• Product Code: QEA
• CFR Regulation Number: 882.1455 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-02
• Decision Date: 2019-07-31
• Summary: summary