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FDA 510(k)

ISEN-Goggles with Data Viewer

K-Number: K163270 · 2017-09-25

ApplicantIsent Tech & Trading Company, Ltd.
Decision Date2017-09-25
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ISEN-Goggles with Data Viewer is a medical device manufactured by Isent Tech & Trading Company, Ltd.. It received FDA 510(k) clearance on 2017-09-25 under approval number K163270. 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 ISEN-Goggles with Data Viewer?

ISEN-Goggles with Data Viewer is a medical device that received FDA 510(k) clearance on 2017-09-25. It is manufactured by Isent Tech & Trading Company, Ltd.. The 510(k) number is K163270.

When was ISEN-Goggles with Data Viewer approved by the FDA?

ISEN-Goggles with Data Viewer received FDA 510(k) clearance on 2017-09-25, under approval number K163270.

What company makes ISEN-Goggles with Data Viewer?

ISEN-Goggles with Data Viewer is manufactured by Isent Tech & Trading Company, Ltd..

What is the FDA product code for ISEN-Goggles with Data Viewer?

The FDA product code for ISEN-Goggles with Data Viewer is GWN.

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.

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