FDA 510(k)

醫療外科口罩（型號：JM92、JM92B）

K 號：K220187 · 2022-03-25

申請人Guangdong Jia Mei Biological Technology Co.Ltd

決定日期2022-03-25

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 (Model: JM92, JM92B) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Jia Mei Biological Technology Co.Ltd. It received FDA 510(k) clearance on 2022-03-25 under 510(k) number K220187. 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 (Model: JM92, JM92B)?

Medical Surgical Mask (Model: JM92, JM92B) is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Guangdong Jia Mei Biological Technology Co.Ltd. The 510(k) number is K220187.

When did Medical Surgical Mask (Model: JM92, JM92B) receive FDA 510(k) clearance?

Medical Surgical Mask (Model: JM92, JM92B) received FDA 510(k) clearance on 2022-03-25, under 510(k) number K220187.

Who is the listed applicant for Medical Surgical Mask (Model: JM92, JM92B)?

The FDA 510(k) record lists Guangdong Jia Mei Biological 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 (Model: JM92, JM92B)?

The FDA product code for Medical Surgical Mask (Model: JM92, JM92B) is FXX.

相關器械（代碼：FXX）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：FXX）

官方來源