醫用口罩，型號名稱：MY020003
K 號：K211165 · 2021-11-09
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器材摘要
Medical Face Masks, Model Name:MY020003 is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Jie Bai Purification Co., Ltd.. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K211165. 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 Face Masks, Model Name:MY020003?
Medical Face Masks, Model Name:MY020003 is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Huizhou Jie Bai Purification Co., Ltd.. The 510(k) number is K211165.
When did Medical Face Masks, Model Name:MY020003 receive FDA 510(k) clearance?
Medical Face Masks, Model Name:MY020003 received FDA 510(k) clearance on 2021-11-09, under 510(k) number K211165.
Who is the listed applicant for Medical Face Masks, Model Name:MY020003?
The FDA 510(k) record lists Huizhou Jie Bai Purification Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medical Face Masks, Model Name:MY020003?
The FDA product code for Medical Face Masks, Model Name:MY020003 is FXX.
相關臨床試驗
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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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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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