IFM外科口罩型號SM3
K 號：K202214 · 2021-03-02
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器材摘要
IFM Surgical Mask Model SM3 is the device name listed in this FDA 510(k) record. The listed applicant is Fssc, LLC. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K202214. 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 IFM Surgical Mask Model SM3?
IFM Surgical Mask Model SM3 is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Fssc, LLC. The 510(k) number is K202214.
When did IFM Surgical Mask Model SM3 receive FDA 510(k) clearance?
IFM Surgical Mask Model SM3 received FDA 510(k) clearance on 2021-03-02, under 510(k) number K202214.
Who is the listed applicant for IFM Surgical Mask Model SM3?
The FDA 510(k) record lists Fssc, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IFM Surgical Mask Model SM3?
The FDA product code for IFM Surgical Mask Model SM3 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
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