FDA 510(k)

Nordiwell Surprotect 面罩

K 號：K210445 · 2021-06-29

申請人Changzhou Combat Protective Equipment Co., Ltd.

決定日期2021-06-29

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

Nordiwell Surprotect Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Combat Protective Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-06-29 under 510(k) number K210445. 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 Nordiwell Surprotect Face Mask?

Nordiwell Surprotect Face Mask is a medical device that received FDA 510(k) clearance on 2021-06-29. The listed applicant is Changzhou Combat Protective Equipment Co., Ltd.. The 510(k) number is K210445.

When did Nordiwell Surprotect Face Mask receive FDA 510(k) clearance?

Nordiwell Surprotect Face Mask received FDA 510(k) clearance on 2021-06-29, under 510(k) number K210445.

Who is the listed applicant for Nordiwell Surprotect Face Mask?

The FDA 510(k) record lists Changzhou Combat Protective Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nordiwell Surprotect Face Mask?

The FDA product code for Nordiwell Surprotect Face Mask is FXX.

其他以 Changzhou Combat Protective Equipment Co., Ltd. 為申請人之記錄

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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。

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