加熱呼吸管
K 號：K243244 · 2025-07-25
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器材摘要
Heated Breathing Tube is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Eda Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K243244. 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 Heated Breathing Tube?
Heated Breathing Tube is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is Guangdong Eda Technology Co., Ltd.. The 510(k) number is K243244.
When did Heated Breathing Tube receive FDA 510(k) clearance?
Heated Breathing Tube received FDA 510(k) clearance on 2025-07-25, under 510(k) number K243244.
Who is the listed applicant for Heated Breathing Tube?
The FDA 510(k) record lists Guangdong Eda Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Heated Breathing Tube?
The FDA product code for Heated Breathing Tube 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。
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, LPK241268Thermalite 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 KgaaK201418日落加熱CPAP管Sunset Healthcare Solutions, Inc.
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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