FDA 510(k)

醫療保護口罩

K 號：K212205 · 2021-10-14

申請人Qinhuangdao Taizhi Medical Technology Co., Ltd.

決定日期2021-10-14

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 Masks is the device name listed in this FDA 510(k) record. The listed applicant is Qinhuangdao Taizhi Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K212205. 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 Masks?

Medical Protective Masks is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Qinhuangdao Taizhi Medical Technology Co., Ltd.. The 510(k) number is K212205.

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

Medical Protective Masks received FDA 510(k) clearance on 2021-10-14, under 510(k) number K212205.

Who is the listed applicant for Medical Protective Masks?

The FDA 510(k) record lists Qinhuangdao Taizhi Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Protective Masks?

The FDA product code for Medical Protective Masks is FXX.

其他以 Qinhuangdao Taizhi Medical Technology Co., Ltd. 為申請人之記錄

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K223686醫療保護口罩 K211451一次性外科口罩（非无菌）

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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