CAF
- 产品代码
- CAF
- 器械名称
- Nebulizer (Direct Patient Interface)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 868.5630
- 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)
- 508 件
该代码近三年的 510(k)（14 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260270 | 2026-06-02 | FindAir Sp. z o.o. | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) 摘要 |
| K251572 | 2025-12-19 | Pari Respiratory Equipment, Inc. | eRapid with eTrack System 摘要 |
| K251659 | 2025-11-14 | Qingdao Future Medical Technology Co., | Mesh Nebulizer (H6) 摘要 |
| K244035 | 2025-09-19 | Shenzhen Jermei Medical Device Technol | Portable mesh nebulizer (JM821) 摘要 |
| K243468 | 2025-07-02 | Joytech Healthcare Co. , Ltd. | Compressor Nebulizer (NB-1100); Compressor Nebulizer 摘要 |
| K250022 | 2025-06-30 | Voluntis | HeroTracker Sense 摘要 |
| K250583 | 2025-06-20 | Hcmed Innovations Co., Ltd. | AdheResp Smart Breath-actuated Mesh Nebulizer 摘要 |
| K242354 | 2025-04-29 | Enchant Tek Co. , Ltd. | AllNEB 摘要 |
| K233553 | 2024-06-18 | Thayer Medical Corporation | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A 摘要 |
| K232507 | 2024-05-10 | Aerogen, Ltd. | Aerogen®Solo Nebulizer System 摘要 |
| K232523 | 2024-04-10 | Mankind Pharma Limited | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 摘要 |
| K231058 | 2024-01-04 | Medline Industries, LP | Hudson RCI® AddiPak® Unit Dose Vial 摘要 |
| K230379 | 2023-11-27 | Dongguan Simzo Electronic Technology C | Portable (Ultrasonic) Nebulizer 摘要 |
| K230602 | 2023-10-31 | Medline Industries, LP | Hudson RCI® TurboMist Nebulizer System 摘要 |
FDA 官方分类页： CAF
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。