Roki醫療口罩
K 號：K214094 · 2022-02-24
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器材摘要
ROKI Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Roki Co., Ltd.. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K214094. 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 ROKI Surgical Mask?
ROKI Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is Roki Co., Ltd.. The 510(k) number is K214094.
When did ROKI Surgical Mask receive FDA 510(k) clearance?
ROKI Surgical Mask received FDA 510(k) clearance on 2022-02-24, under 510(k) number K214094.
Who is the listed applicant for ROKI Surgical Mask?
The FDA 510(k) record lists Roki Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ROKI Surgical Mask?
The FDA product code for ROKI Surgical Mask 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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