AirLife 成人加熱線電路
K 號：K153234 · 2016-07-07
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器材摘要
AirLife Adult Heated Wire Circuit is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion, Inc.. It received FDA 510(k) clearance on 2016-07-07 under 510(k) number K153234. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AirLife Adult Heated Wire Circuit?
AirLife Adult Heated Wire Circuit is a medical device that received FDA 510(k) clearance on 2016-07-07. The listed applicant is Carefusion, Inc.. The 510(k) number is K153234.
When did AirLife Adult Heated Wire Circuit receive FDA 510(k) clearance?
AirLife Adult Heated Wire Circuit received FDA 510(k) clearance on 2016-07-07, under 510(k) number K153234.
Who is the listed applicant for AirLife Adult Heated Wire Circuit?
The FDA 510(k) record lists Carefusion, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirLife Adult Heated Wire Circuit?
The FDA product code for AirLife Adult Heated Wire Circuit is BZE.
相關臨床試驗
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。
其他以 Carefusion, Inc. 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：BZE）
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。
K252066inspired™ 加熱呼吸回路 (510-008)；inspired™ 加熱呼吸回路 (510-009)；inspired™ 自動進料濕化室 (VHC10)；inspired™ 自動進料濕化室 (VHC20)Vincent Healthcare Products LimitedK253322Hudson RCI®嬰兒乾燥技術TM呼吸回路 (HUD99060 / 乾燥技術配78英寸嬰兒回路，HUD99060KIT / 乾燥技術配78英寸嬰兒回路套件，HUD99001KIT / 单臂嬰兒回路乾燥技術套件，HUD99009KIT / 乾燥技術配60英寸嬰兒回路套件，HUD99018KIT / 乾燥技術配44英寸嬰兒回路套件，HUD870NKIT / 乾燥技術嬰兒配件袋，HUD1631 / 嬰兒Y型接頭配轉動環)Medline Industries, LPK243244加熱呼吸管Guangdong Eda Technology Co., Ltd.K241268Thermalite 加熱 CPAP 管道 (CTUBH06H15DS-2, CTUBH15-DS)Exceleron MedicalK234032Hudson RCI Dri-Tech 呼吸回路；HUD99035/Dri-Tech 成人回路；HUD99035KIT/Dri-Tech 成人回路組合包；HUD99098KIT/單肢成人 Dri-Tech 組合包；HUD99098KITF/單肢成人 Dri-Tech 過濾器組合包；HUD900/Dri-Tech 呼吸器配件；HUD901/Dri-Tech 呼吸器配件延長線Medline Industries, LPK222822VentStar Helix雙加熱(N) Plus (MP02650)，VentStar Helix加熱(N) Plus (MP02608)Draegerwerk AG & CO Kgaa
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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