醫用外科口罩（非無菌）
K 號：K202761 · 2021-04-11
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決定日期2021-04-11
產品代碼FXX
諮詢委員會SU
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決定相當於
器材摘要
Medical Surgical Mask (Non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.. It received FDA 510(k) clearance on 2021-04-11 under 510(k) number K202761. 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 (Non-sterile)?
Medical Surgical Mask (Non-sterile) is a medical device that received FDA 510(k) clearance on 2021-04-11. The listed applicant is Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.. The 510(k) number is K202761.
When did Medical Surgical Mask (Non-sterile) receive FDA 510(k) clearance?
Medical Surgical Mask (Non-sterile) received FDA 510(k) clearance on 2021-04-11, under 510(k) number K202761.
Who is the listed applicant for Medical Surgical Mask (Non-sterile)?
The FDA 510(k) record lists Guangdong Goodfeeling Hygiene Material Tec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medical Surgical Mask (Non-sterile)?
The FDA product code for Medical Surgical Mask (Non-sterile) is FXX.
相關臨床試驗
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。
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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