INTAI外科口罩（非无菌）
K 號：K210422 · 2022-03-30
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器材摘要
INTAI Surgical Mask (non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Intai Technology Corp.. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K210422. 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 INTAI Surgical Mask (non-sterile)?
INTAI Surgical Mask (non-sterile) is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Intai Technology Corp.. The 510(k) number is K210422.
When did INTAI Surgical Mask (non-sterile) receive FDA 510(k) clearance?
INTAI Surgical Mask (non-sterile) received FDA 510(k) clearance on 2022-03-30, under 510(k) number K210422.
Who is the listed applicant for INTAI Surgical Mask (non-sterile)?
The FDA 510(k) record lists Intai Technology Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INTAI Surgical Mask (non-sterile)?
The FDA product code for INTAI Surgical Mask (non-sterile) 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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