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FDA 510(k)

外科口罩-型號 CR02-2, CR02

K 號:K202424 · 2021-03-31

決定日期2021-03-31
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

Surgical Mask-Models CR02-2, CR02 is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Xinbao Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K202424. 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 Surgical Mask-Models CR02-2, CR02?

Surgical Mask-Models CR02-2, CR02 is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Foshan Xinbao Technology Co., Ltd.. The 510(k) number is K202424.

When did Surgical Mask-Models CR02-2, CR02 receive FDA 510(k) clearance?

Surgical Mask-Models CR02-2, CR02 received FDA 510(k) clearance on 2021-03-31, under 510(k) number K202424.

Who is the listed applicant for Surgical Mask-Models CR02-2, CR02?

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

What is the FDA product code for Surgical Mask-Models CR02-2, CR02?

The FDA product code for Surgical Mask-Models CR02-2, CR02 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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