CBK
- 产品代码
- CBK
- 器械名称
- Ventilator, Continuous, Facility Use
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 868.5895
- FDA 专业组
- Anesthesiology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属生命支持/维持器械
- 该代码近三年的 510(k)
- 505 件
该代码近三年的 510(k)（16 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253647 | 2026-05-07 | Draegerwerk AG & CO Kgaa | Evita (V800); Evita (V600) 摘要 |
| K252663 | 2026-04-14 | Iconic Solutions by Murcia, SL | Inbentus Versatile 摘要 |
| K251888 | 2026-03-12 | Hsiner Co., Ltd. | VPAP Pediatric Face Mask 摘要 |
| K232365 | 2025-12-19 | Oconnell Regulatory Consultants, Inc. | Vivo 45 LS 摘要 |
| K252173 | 2025-09-10 | Fisher & Paykel Healthcare, Ltd. | F&P OptiNIV Hospital Vented Full Face Mask Compatibl 摘要 |
| K243767 | 2025-08-28 | Shenzhen Mindray Bio-Medical Electroni | SV600, SV800 Ventilator 摘要 |
| K251133 | 2025-05-08 | Telesair, Inc. | AVEA disposable expiratory filter/water trap (11790) 摘要 |
| K243394 | 2024-12-30 | Respironics, Inc. | AF531 Oro-Nasal SE Face Mask 摘要 |
| K233486 | 2024-12-13 | ZOLL Medical Corporation | 731 Series Ventilator 摘要 |
| K223120 | 2024-12-02 | Flight Medical Innovations , Ltd. | Ventoux VC2; Ventoux VC3 摘要 |
| K241135 | 2024-11-13 | Corvent Medical, Inc. | RESPOND(R) Ventilator 摘要 |
| K241943 | 2024-08-28 | Sleepnet Corporation | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face 摘要 |
| K232836 | 2024-08-14 | Dimar S.P.A. | Family of DIMAR DMAX NIV masks 摘要 |
| K240807 | 2024-08-13 | Ventis Medical, Inc. | VM-2000 摘要 |
| K241520 | 2024-06-27 | Sleepnet Corporation | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face A 摘要 |
| K231778 | 2024-03-01 | Nihon Kohden Orangemed, LLC | Nihon Kohden NKV-550 Series Ventilator System 摘要 |
FDA 官方分类页： CBK
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。