TNI 轟流 50
K 號：K180474 · 2018-10-18
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器材摘要
TNI softFlow 50 is the device name listed in this FDA 510(k) record. The listed applicant is Tni Medical AG. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K180474. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TNI softFlow 50?
TNI softFlow 50 is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Tni Medical AG. The 510(k) number is K180474.
When did TNI softFlow 50 receive FDA 510(k) clearance?
TNI softFlow 50 received FDA 510(k) clearance on 2018-10-18, under 510(k) number K180474.
Who is the listed applicant for TNI softFlow 50?
The FDA 510(k) record lists Tni Medical AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TNI softFlow 50?
The FDA product code for TNI softFlow 50 is BTT.
相關臨床試驗
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相關器械（代碼：BTT）
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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