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FDA 510(k)

醫療手術口罩,型號:2626-7

K 號:K220067 · 2022-08-30

決定日期2022-08-30
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 Surgery Mask, Model:2626-7 is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Missadola Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K220067. 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 Surgery Mask, Model:2626-7?

Medical Surgery Mask, Model:2626-7 is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Dongguan Missadola Technology Co., Ltd.. The 510(k) number is K220067.

When did Medical Surgery Mask, Model:2626-7 receive FDA 510(k) clearance?

Medical Surgery Mask, Model:2626-7 received FDA 510(k) clearance on 2022-08-30, under 510(k) number K220067.

Who is the listed applicant for Medical Surgery Mask, Model:2626-7?

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

What is the FDA product code for Medical Surgery Mask, Model:2626-7?

The FDA product code for Medical Surgery Mask, Model:2626-7 is FXX.

相關臨床試驗

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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。

官方來源

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