FDA 510(k)

醫療外科口罩

K 號：K212299 · 2022-01-04

決定日期2022-01-04

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

Medical Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wepon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-04 under 510(k) number K212299. 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 Medical Surgical Mask?

Medical Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-01-04. The listed applicant is Wepon Medical Technology Co., Ltd.. The 510(k) number is K212299.

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

Medical Surgical Mask received FDA 510(k) clearance on 2022-01-04, under 510(k) number K212299.

Who is the listed applicant for Medical Surgical Mask?

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

What is the FDA product code for Medical Surgical Mask?

The FDA product code for Medical Surgical Mask is FXX.

其他以 Wepon Medical Technology Co., Ltd. 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。

K231723單次使用无菌安全針頭 K231727无菌單次使用自閉針筒（含/不含針）K231720單次使用无菌皮下針頭 K231729單次使用无菌針筒（含/不含針）

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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