外科口罩，型號：EFMDS-L50Pn BLU
K 號：K230380 · 2023-08-03
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器材摘要
Surgical Face Masks, Model: EFMDS-L50Pn BLU is the device name listed in this FDA 510(k) record. The listed applicant is Iris USA. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K230380. 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 Surgical Face Masks, Model: EFMDS-L50Pn BLU?
Surgical Face Masks, Model: EFMDS-L50Pn BLU is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Iris USA. The 510(k) number is K230380.
When did Surgical Face Masks, Model: EFMDS-L50Pn BLU receive FDA 510(k) clearance?
Surgical Face Masks, Model: EFMDS-L50Pn BLU received FDA 510(k) clearance on 2023-08-03, under 510(k) number K230380.
Who is the listed applicant for Surgical Face Masks, Model: EFMDS-L50Pn BLU?
The FDA 510(k) record lists Iris USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Surgical Face Masks, Model: EFMDS-L50Pn BLU?
The FDA product code for Surgical Face Masks, Model: EFMDS-L50Pn BLU 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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