東海祥外科口罩
K 號：K212203 · 2022-04-07
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決定日期2022-04-07
產品代碼FXX
諮詢委員會SU
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決定相當於
器材摘要
Dong Hai Xiang Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Taizhou Donghaixiang Protective Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-04-07 under 510(k) number K212203. 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 Dong Hai Xiang Surgical Mask?
Dong Hai Xiang Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-04-07. The listed applicant is Taizhou Donghaixiang Protective Equipment Co., Ltd.. The 510(k) number is K212203.
When did Dong Hai Xiang Surgical Mask receive FDA 510(k) clearance?
Dong Hai Xiang Surgical Mask received FDA 510(k) clearance on 2022-04-07, under 510(k) number K212203.
Who is the listed applicant for Dong Hai Xiang Surgical Mask?
The FDA 510(k) record lists Taizhou Donghaixiang Protective Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dong Hai Xiang Surgical Mask?
The FDA product code for Dong Hai Xiang Surgical Mask 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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