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FDA 510(k)

HX Device

K-Number: K173919 · 2018-03-20

ApplicantHuman Extension , Ltd.
Decision Date2018-03-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HX Device is a medical device manufactured by Human Extension , Ltd.. It received FDA 510(k) clearance on 2018-03-20 under approval number K173919. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HX Device?

HX Device is a medical device that received FDA 510(k) clearance on 2018-03-20. It is manufactured by Human Extension , Ltd.. The 510(k) number is K173919.

When was HX Device approved by the FDA?

HX Device received FDA 510(k) clearance on 2018-03-20, under approval number K173919.

What company makes HX Device?

HX Device is manufactured by Human Extension , Ltd..

What is the FDA product code for HX Device?

The FDA product code for HX Device is GCJ.

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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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