FDA 510(k)

VisualEyes

K-Number: K163149 · 2017-04-26

Decision Date2017-04-26

Product CodeGWN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

VisualEyes is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K163149. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisualEyes?

VisualEyes is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Interacoustics A/S. The 510(k) number is K163149.

When did VisualEyes receive FDA 510(k) clearance?

VisualEyes received FDA 510(k) clearance on 2017-04-26, under 510(k) number K163149.

Who is the listed applicant for VisualEyes?

The FDA 510(k) record lists Interacoustics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VisualEyes?

The FDA product code for VisualEyes is GWN.

Other records listing Interacoustics A/S 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.

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Related Devices (Code: GWN)

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Official Source

View on FDA Database →

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