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FDA 510(k)

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K 號:K202107 · 2021-01-15

決定日期2021-01-15
產品代碼FXX
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Medical Protective Mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K202107. 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 Medical Protective Mask?

Medical Protective Mask is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K202107.

When did Medical Protective Mask receive FDA 510(k) clearance?

Medical Protective Mask received FDA 510(k) clearance on 2021-01-15, under 510(k) number K202107.

Who is the listed applicant for Medical Protective Mask?

The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Protective Mask?

The FDA product code for Medical Protective Mask is FXX.

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其他以 Guangdong Kingfa Sci. & Tech.Co., Ltd. 為申請人之記錄

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相關器械(代碼:FXX)

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官方來源

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