HX設備
K 號：K173919 · 2018-03-20
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器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：GCJ）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
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