FDA 510(k)

摩特克斯防霧外科口罩

K 號：K201549 · 2020-08-26

決定日期2020-08-26

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

Motex Anti-Fog Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Modern Healthcare Corp.. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K201549. 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 Motex Anti-Fog Surgical Face Mask?

Motex Anti-Fog Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Modern Healthcare Corp.. The 510(k) number is K201549.

When did Motex Anti-Fog Surgical Face Mask receive FDA 510(k) clearance?

Motex Anti-Fog Surgical Face Mask received FDA 510(k) clearance on 2020-08-26, under 510(k) number K201549.

Who is the listed applicant for Motex Anti-Fog Surgical Face Mask?

The FDA 510(k) record lists Modern Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Motex Anti-Fog Surgical Face Mask?

The FDA product code for Motex Anti-Fog Surgical Face Mask is FXX.

其他以 Modern Healthcare Corp. 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。

K191898無菌乳膠無粉外科手術手套

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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