MSX
- 产品代码
- MSX
- 器械名称
- System, Network And Communication, Physiological Monitors
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.2300
- FDA 专业组
- Cardiovascular
- 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)
- 119 件
该代码近三年的 510(k)(11 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260211 | 2026-08-13 | Hill-Rom, Inc. | Dashboard (P007000) | |
| K261367 | 2026-07-26 | Corsano Health B.V. | Corsano CardioWatch 287-2 System | |
| K253654 | 2026-03-30 | Philips Medizin Systeme Böblingen GmbH | IntelliVue Measurement Rack 6000 (867317) | FDA |
| K243270 | 2025-09-30 | Tigerconnect | TigerConnect Alarm Management | |
| K242728 | 2025-07-31 | Shenzhen Mindray Bio-Medical Electroni | BeneVision Central Monitoring System | |
| K242750 | 2025-06-05 | Nihon Kohden Digital Health Solutions, | Central Station | |
| K242842 | 2025-01-08 | Sibel Health, Inc. | ANNE View, Central Hub | |
| K241397 | 2024-11-14 | Hinlab Sas | Hinscope | |
| K233834 | 2024-07-12 | Draeger Medical Systems, Inc. | Infinity Gateway Suite | FDA |
| K233418 | 2024-05-09 | Biofourmis Singapore Pte., Ltd. | Biofourmis Everion+ (G2) | |
| K232548 | 2024-03-22 | Corsano Health B.V. | Corsano CardioWatch 287-2 System |
FDA 官方分类页: MSX
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。