DSA
- 产品代码
- DSA
- 器械名称
- Cable, Transducer And Electrode, Patient, (Including Connector)
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.2900
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 105 件
该代码近三年的 510(k)(9 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K254114 | 2026-01-18 | Baylis Medical Technologies, Inc. | Baylis Connector Cable 摘要 |
| K252827 | 2025-12-01 | Drägerwerk AG & Co. KGaA | IBP cable Becton Dickinson (2606488); IBP cable Edwa 摘要 |
| K251669 | 2025-09-30 | Shanghai Draeger Medical Instrument Co | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; I 摘要 |
| K242986 | 2025-05-02 | Beijing Rongrui-Century Science & Tech | SpO2 Extension Cable 摘要 |
| K243545 | 2025-01-17 | Philips Medizin Systeme Böblingen GmbH | Philips Reusable ECG Lead Sets and Trunk Cables : Mo 摘要 |
| K240087 | 2024-09-13 | Ivy Biomedical Systems, Inc. | RT Carbon ECG Leads 摘要 |
| K240377 | 2024-05-07 | Stryker Physio-Control | LIFEPAK® ECG Cables 摘要 |
| K240156 | 2024-04-30 | Physio-Control, Inc. | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces 摘要 |
| K222712 | 2023-11-22 | Fogg System Company, Inc. | Fogg System Patient Monitoring Cables 摘要 |
FDA 官方分类页: DSA
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。