TNI Clear-Guard™ 3 角度呼吸過濾器（1545020）
K 號：K223258 · 2023-06-15
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器材摘要
TNI Clear-Guard™ 3 angled breathing filter (1545020) is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical , Ltd.. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K223258. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TNI Clear-Guard™ 3 angled breathing filter (1545020)?
TNI Clear-Guard™ 3 angled breathing filter (1545020) is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Intersurgical , Ltd.. The 510(k) number is K223258.
When did TNI Clear-Guard™ 3 angled breathing filter (1545020) receive FDA 510(k) clearance?
TNI Clear-Guard™ 3 angled breathing filter (1545020) received FDA 510(k) clearance on 2023-06-15, under 510(k) number K223258.
Who is the listed applicant for TNI Clear-Guard™ 3 angled breathing filter (1545020)?
The FDA 510(k) record lists Intersurgical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020)?
The FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020) is CAH.
相關臨床試驗
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相關器械（代碼：CAH）
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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