LM外科口罩第3級，LM外科口罩第2級，
K 號：K211378 · 2021-12-16
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器材摘要
LM Surgical Mask Level 3, LM Surgical Mask Level 2, is the device name listed in this FDA 510(k) record. The listed applicant is Liberty Mask, LLC. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K211378. 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 LM Surgical Mask Level 3, LM Surgical Mask Level 2,?
LM Surgical Mask Level 3, LM Surgical Mask Level 2, is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Liberty Mask, LLC. The 510(k) number is K211378.
When did LM Surgical Mask Level 3, LM Surgical Mask Level 2, receive FDA 510(k) clearance?
LM Surgical Mask Level 3, LM Surgical Mask Level 2, received FDA 510(k) clearance on 2021-12-16, under 510(k) number K211378.
Who is the listed applicant for LM Surgical Mask Level 3, LM Surgical Mask Level 2,?
The FDA 510(k) record lists Liberty Mask, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LM Surgical Mask Level 3, LM Surgical Mask Level 2,?
The FDA product code for LM Surgical Mask Level 3, LM Surgical Mask Level 2, 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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