加熱冷卻系統 3T
K 號：K220635 · 2022-11-16
廣告
器材摘要
Heater-Cooler System 3T is the device name listed in this FDA 510(k) record. The listed applicant is Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K220635. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Heater-Cooler System 3T?
Heater-Cooler System 3T is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K220635.
When did Heater-Cooler System 3T receive FDA 510(k) clearance?
Heater-Cooler System 3T received FDA 510(k) clearance on 2022-11-16, under 510(k) number K220635.
Who is the listed applicant for Heater-Cooler System 3T?
The FDA 510(k) record lists Livanova Deutschland, GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Heater-Cooler System 3T?
The FDA product code for Heater-Cooler System 3T is DWC.
相關臨床試驗
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其他以 Livanova Deutschland, GmbH 為申請人之記錄
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。
相關器械（代碼：DWC）
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。
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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