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FDA 510(k)

交叉保護ResQ300 Plus手術口罩

K 號:K212273 · 2022-08-17

決定日期2022-08-17
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

Cross Protection ResQ300 Plus Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Cross Protection (M) Sdn Bhd. It received FDA 510(k) clearance on 2022-08-17 under 510(k) number K212273. 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 Cross Protection ResQ300 Plus Surgical Face Mask?

Cross Protection ResQ300 Plus Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2022-08-17. The listed applicant is Cross Protection (M) Sdn Bhd. The 510(k) number is K212273.

When did Cross Protection ResQ300 Plus Surgical Face Mask receive FDA 510(k) clearance?

Cross Protection ResQ300 Plus Surgical Face Mask received FDA 510(k) clearance on 2022-08-17, under 510(k) number K212273.

Who is the listed applicant for Cross Protection ResQ300 Plus Surgical Face Mask?

The FDA 510(k) record lists Cross Protection (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cross Protection ResQ300 Plus Surgical Face Mask?

The FDA product code for Cross Protection ResQ300 Plus Surgical Face Mask 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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