Decision Date2018-03-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
HX Device is the device name listed in this FDA 510(k) record. The listed applicant is Human Extension , Ltd.. It received FDA 510(k) clearance on 2018-03-20 under 510(k) 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. The listed applicant is Human Extension , Ltd.. The 510(k) number is K173919.
When did HX Device receive FDA 510(k) clearance?
HX Device received FDA 510(k) clearance on 2018-03-20, under 510(k) number K173919.
Who is the listed applicant for HX Device?
The FDA 510(k) record lists Human Extension , Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.