FDA 510(k)

M1外科口罩

K 號：K202457 · 2021-04-29

申請人CHISON Medical Technologies Co., Ltd.

決定日期2021-04-29

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

M1 Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2021-04-29 under 510(k) number K202457. 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 M1 Surgical Face Mask?

M1 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-04-29. The listed applicant is CHISON Medical Technologies Co., Ltd.. The 510(k) number is K202457.

When did M1 Surgical Face Mask receive FDA 510(k) clearance?

M1 Surgical Face Mask received FDA 510(k) clearance on 2021-04-29, under 510(k) number K202457.

Who is the listed applicant for M1 Surgical Face Mask?

The FDA 510(k) record lists CHISON Medical Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M1 Surgical Face Mask?

The FDA product code for M1 Surgical Face Mask is FXX.

其他以 CHISON Medical Technologies 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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