Hygenix
K 號：K232797 · 2023-12-11
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器材摘要
Hygenix is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hygenix Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-12-11 under 510(k) number K232797. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Hygenix?
Hygenix is a medical device that received FDA 510(k) clearance on 2023-12-11. The listed applicant is Shenzhen Hygenix Industrial Co., Ltd.. The 510(k) number is K232797.
When did Hygenix receive FDA 510(k) clearance?
Hygenix received FDA 510(k) clearance on 2023-12-11, under 510(k) number K232797.
Who is the listed applicant for Hygenix?
The FDA 510(k) record lists Shenzhen Hygenix Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hygenix?
The FDA product code for Hygenix is FXX.
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相關器械（代碼：FXX）
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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