一次性外科口罩（型號：YYKZ-01）
K 號：K210845 · 2021-10-12
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器材摘要
Disposable Surgical Mask (Model: YYKZ-01) is the device name listed in this FDA 510(k) record. The listed applicant is Jiaxing Amazing Travel-Ware Co., Ltd.. It received FDA 510(k) clearance on 2021-10-12 under 510(k) number K210845. 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 Disposable Surgical Mask (Model: YYKZ-01)?
Disposable Surgical Mask (Model: YYKZ-01) is a medical device that received FDA 510(k) clearance on 2021-10-12. The listed applicant is Jiaxing Amazing Travel-Ware Co., Ltd.. The 510(k) number is K210845.
When did Disposable Surgical Mask (Model: YYKZ-01) receive FDA 510(k) clearance?
Disposable Surgical Mask (Model: YYKZ-01) received FDA 510(k) clearance on 2021-10-12, under 510(k) number K210845.
Who is the listed applicant for Disposable Surgical Mask (Model: YYKZ-01)?
The FDA 510(k) record lists Jiaxing Amazing Travel-Ware Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Surgical Mask (Model: YYKZ-01)?
The FDA product code for Disposable Surgical Mask (Model: YYKZ-01) 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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