FDA 510(k)

Unico 高性能外科口罩，配臉盾的高性能外科口罩

K 號：K210147 · 2021-12-22

決定日期2021-12-22

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

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield is the device name listed in this FDA 510(k) record. The listed applicant is Unicoglobal, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K210147. 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 Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield?

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Unicoglobal, Inc.. The 510(k) number is K210147.

When did Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield receive FDA 510(k) clearance?

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield received FDA 510(k) clearance on 2021-12-22, under 510(k) number K210147.

Who is the listed applicant for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield?

The FDA 510(k) record lists Unicoglobal, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield?

The FDA product code for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield is FXX.

其他以 Unicoglobal, Inc. 為申請人之記錄

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。

K203539Unico Global 第三級手術袍（膠膜強化SMS），Unico Global 第三級手術袍（PP+PE）

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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官方來源

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