FDA 510(k)

EyeBOX

K-Number: K201841 · 2020-09-06

Decision Date2020-09-06

Product CodeQEA

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EyeBOX is the device name listed in this FDA 510(k) record. The listed applicant is Oculogica, Inc.. It received FDA 510(k) clearance on 2020-09-06 under 510(k) number K201841. The device is classified under product code QEA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EyeBOX?

EyeBOX is a medical device that received FDA 510(k) clearance on 2020-09-06. The listed applicant is Oculogica, Inc.. The 510(k) number is K201841.

When did EyeBOX receive FDA 510(k) clearance?

EyeBOX received FDA 510(k) clearance on 2020-09-06, under 510(k) number K201841.

Who is the listed applicant for EyeBOX?

The FDA 510(k) record lists Oculogica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EyeBOX?

The FDA product code for EyeBOX is QEA.

Other records listing Oculogica, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254086EyeBOX SNAP K242116EyeBOX EBX-4.1 K212310EyeBOX (Model EBX-4)K191183EyeBOX

Related Devices (Code: QEA)

K254086EyeBOX SNAPOculogica, Inc.K242116EyeBOX EBX-4.1Oculogica, Inc.K212310EyeBOX (Model EBX-4)Oculogica, Inc.K202927EYE-SYNCSyncthink, Inc.K191183EyeBOXOculogica, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.