建宇醫療口罩
K 號：K201754 · 2020-12-30
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器材摘要
JianYu Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jianyu Health Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-30 under 510(k) number K201754. 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 JianYu Surgical Mask?
JianYu Surgical Mask is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is Jiangsu Jianyu Health Medical Co., Ltd.. The 510(k) number is K201754.
When did JianYu Surgical Mask receive FDA 510(k) clearance?
JianYu Surgical Mask received FDA 510(k) clearance on 2020-12-30, under 510(k) number K201754.
Who is the listed applicant for JianYu Surgical Mask?
The FDA 510(k) record lists Jiangsu Jianyu Health Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for JianYu Surgical Mask?
The FDA product code for JianYu Surgical Mask is FXX.
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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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