VisualEyes
K-Number: K163149 · 2017-04-26
ApplicantInteracoustics A/S
Decision Date2017-04-26
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
VisualEyes is a medical device manufactured by Interacoustics A/S. It received FDA 510(k) clearance on 2017-04-26 under approval 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. It is manufactured by Interacoustics A/S. The 510(k) number is K163149.
When was VisualEyes approved by the FDA?
VisualEyes received FDA 510(k) clearance on 2017-04-26, under approval number K163149.
What company makes VisualEyes?
VisualEyes is manufactured by Interacoustics A/S.
What is the FDA product code for VisualEyes?
The FDA product code for VisualEyes is 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.