一次性醫療口罩
K 號：K210018 · 2021-04-11
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器材摘要
Disposable Medical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Diasia Biomedical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-04-11 under 510(k) number K210018. 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 Medical Mask?
Disposable Medical Mask is a medical device that received FDA 510(k) clearance on 2021-04-11. The listed applicant is Diasia Biomedical Technology Co., Ltd.. The 510(k) number is K210018.
When did Disposable Medical Mask receive FDA 510(k) clearance?
Disposable Medical Mask received FDA 510(k) clearance on 2021-04-11, under 510(k) number K210018.
Who is the listed applicant for Disposable Medical Mask?
The FDA 510(k) record lists Diasia Biomedical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Medical Mask?
The FDA product code for Disposable Medical 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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