MHX
- 产品代码
- MHX
- 器械名称
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.1025
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 429 件
该代码近三年的 510(k)（28 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260343 | 2026-08-28 | GE Healthcare Finland Oy | Carescape Canvas 1000; Carescape Canvas Smart Displa 摘要 |
| K260579 | 2026-08-20 | Draeger Medical Systems, Inc. | Infinity® Acute Care System (IACS) VG8.1 摘要 |
| K251508 | 2026-08-06 | Edan Instruments, Inc. | Telemetry Monitor (iT30, iT50) 摘要 |
| K253277 | 2026-07-24 | Ge Medical Systems Information Technol | Monitor B105M; Monitor B125M; Monitor B155M; Monitor 摘要 |
| K254209 | 2026-06-04 | Masimo Corporation | Radius VSM and Accessories 摘要 |
| K252840 | 2026-05-29 | Global Instrumentation, LLC | M12 Telemetry System 摘要 |
| K260098 | 2026-05-20 | Shenzhen Mindray Bio-Medical Electroni | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/G 摘要 |
| K250349 | 2026-04-24 | Shanghai Draeger Medical Instrument Co | Vista CMS 摘要 |
| K253170 | 2026-04-16 | Shenzhen Mindray Bio-Medical Electroni | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 摘要 |
| K252250 | 2026-04-10 | Shanghai Draeger Medical Instrument Co | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US 摘要 |
| K252726 | 2026-02-06 | Philips Medizin Systeme Boeblingen Gmb | IntelliVue Multi-Measurement Module X3 (867030); Int 摘要 |
| K252589 | 2026-01-09 | AliveCor, Inc. | Corvair Monza 摘要 |
| K250854 | 2025-12-17 | Shenzhen Comen Medical Instruments Co. | Multi-parameter Patient Monitor (N10); Multi-parame 摘要 |
| K251702 | 2025-11-10 | Philips Medizin Systeme Böblingen GmbH | IntelliVue Patient Monitor MX750; IntelliVue Patient 摘要 |
| K251146 | 2025-10-17 | Philips Medizin Systeme Boeblingen Gmb | IntelliVue Patient monitors MX400, MX450, MX500, MX5 摘要 |
| K250453 | 2025-09-02 | Philips Medizin Systeme Böblingen GmbH | IntelliVue Patient Monitor 6100 (6100); IntelliVue P 摘要 |
| K250179 | 2025-07-29 | Edan Instruments, Inc. | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) 摘要 |
| K242562 | 2025-07-09 | Ge Medical Systems Information Technol | Monitor B105M; Monitor B125M; Monitor B155M; Monitor 摘要 |
| K250757 | 2025-05-29 | Masimo Corporation | Radius VSM and Accessories 摘要 |
| K242962 | 2025-05-05 | Philips Medizin Systeme Böblingen GmbH | Telemetry Monitor 5500 Release 4.0 (867232) 摘要 |
| K240312 | 2024-08-01 | Draeger Medical Systems, Inc. | Infinity CentralStation Wide 摘要 |
| K240320 | 2024-06-28 | Edan Instruments, Inc. | Patient Monitor (RespArray) 摘要 |
| K231010 | 2024-06-07 | AliveCor, Inc. | Corvair 摘要 |
| K232962 | 2024-04-19 | Edan Instruments, Inc. | Patient Monitor (iX10, iX12, iX15) 摘要 |
| K232694 | 2024-02-05 | Edan Instruments, Inc. | Central Monitoring System (MFM-CMS) 摘要 |
| K231671 | 2023-12-19 | Philips Medizin Systeme Boeblingen Gmb | IntelliVue Patient Monitor MX750 (866471), IntelliVu 摘要 |
| K230604 | 2023-11-22 | Philips Medizin Systeme Boeblingen Gmb | IntelliVue Patient Monitor MX100 (867033), IntelliVu 摘要 |
| K231477 | 2023-10-17 | Draeger Medical Systems, Inc. | Infinity CentralStation Wide, Infinity M300, Infinit 摘要 |
FDA 官方分类页： MHX
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。