BTT
- 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)
- 222 件
该代码近三年的 510(k)（17 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K262268 | 2026-08-27 | Fisher and Paykel Healthcare Limited | Optiflow Oxygen Kit (AA484J) 摘要 |
| K254078 | 2026-04-13 | Vapotherm, Inc. | HVT 2.0 摘要 |
| K251448 | 2026-01-16 | Flexicare Medical Limited. | FL-10000U Respiratory Humidifier 摘要 |
| K251419 | 2026-01-14 | Laboratorios Biogalenic S.A. DE C.V. | Laboratorios Biogalenic Sterile Water for Inhalation 摘要 |
| K253479 | 2025-12-19 | Fisher & Paykel Healthcare, Ltd. | Optiflow Switch+ Filtered Nasal Interface with CO2 S 摘要 |
| K250312 | 2025-07-02 | Medline Industries, LP | Hudson RCI® Comfort Flo Nasal Cannula Premature, Inf 摘要 |
| K251611 | 2025-06-25 | Fisher & Paykel Healthcare, Ltd. | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ 摘要 |
| K242717 | 2025-01-30 | Laboratorios Biogalenic S.A. DE C.V. | Laboratorios Biogalenic Sterile Water for Inhalation 摘要 |
| K241778 | 2024-12-19 | Medline Industries, LP | Hudson RCI Comfort Flo® CubCannula 摘要 |
| K240163 | 2024-09-27 | Medline Industries, LP | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® C 摘要 |
| K234058 | 2024-08-08 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow Filtered Nasal Interface with Anesthesi 摘要 |
| K233707 | 2024-06-14 | Invent Medical Corporation | HFT150 摘要 |
| K233821 | 2024-06-13 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow Oxygen Kit (AA451J) 摘要 |
| K222292 | 2024-05-08 | Fisher & Paykel Healthcare | F&P myAirvo 3 摘要 |
| K231956 | 2024-02-07 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow+ Duet Nasal Cannula 摘要 |
| K230559 | 2023-10-26 | Medline Industries, Inc. | Hudson RCI® Disposable Humidifier with 4 PSI Pressur 摘要 |
| K223863 | 2023-10-13 | Telesair, Inc. | BONHAWA Respiratory Humidifier 摘要 |
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。