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BTT

Humidifier, Respiratory Gas, (Direct Patient Interface)

产品代码
BTT
器械名称
Humidifier, Respiratory Gas, (Direct Patient Interface)
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 868.5450
FDA 专业组
Anesthesiology
上市路径
需提交 510(k) 上市前通告
该代码近三年的 510(k)
17 件
其中 Summary 已存档
16 份,可直接下载
FDA 历史累计 510(k)
222 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(17 件)

数据窗口为最近三年。最新一件:2026-08-27。

510(k) 号批准日期申请人器械名称摘要
K2622682026-08-27Fisher and Paykel Healthcare LimitedOptiflow Oxygen Kit (AA484J)PDF
K2540782026-04-13Vapotherm, Inc.HVT 2.0PDF
K2514482026-01-16Flexicare Medical Limited.FL-10000U Respiratory HumidifierPDF
K2514192026-01-14Laboratorios Biogalenic S.A. DE C.V.Laboratorios Biogalenic Sterile Water for Inhalation…FDA
K2534792025-12-19Fisher & Paykel Healthcare, Ltd.Optiflow Switch+ Filtered Nasal Interface with CO2 S…PDF
K2503122025-07-02Medline Industries, LPHudson RCI® Comfort Flo Nasal Cannula Premature, Inf…PDF
K2516112025-06-25Fisher & Paykel Healthcare, Ltd.Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ …PDF
K2427172025-01-30Laboratorios Biogalenic S.A. DE C.V.Laboratorios Biogalenic Sterile Water for Inhalation…PDF
K2417782024-12-19Medline Industries, LPHudson RCI Comfort Flo® CubCannula™PDF
K2401632024-09-27Medline Industries, LPHudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® C…PDF
K2340582024-08-08Fisher & Paykel Healthcare, Ltd.F&P Optiflow Filtered Nasal Interface with Anesthesi…PDF
K2337072024-06-14Invent Medical CorporationHFT150PDF
K2338212024-06-13Fisher & Paykel Healthcare, Ltd.F&P Optiflow Oxygen Kit (AA451J)PDF
K2222922024-05-08Fisher & Paykel HealthcareF&P myAirvo 3PDF
K2319562024-02-07Fisher & Paykel Healthcare, Ltd.F&P Optiflow+ Duet Nasal CannulaPDF
K2305592023-10-26Medline Industries, Inc.Hudson RCI® Disposable Humidifier with 4 PSI Pressur…PDF
K2238632023-10-13Telesair, Inc.BONHAWA Respiratory HumidifierPDF

其中 16 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: BTT
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。