MWI
- 产品代码
- MWI
- 器械名称
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- 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
- 可走第三方审查
- 该代码近三年的 510(k)
- 308 件
该代码近三年的 510(k)（22 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260438 | 2026-08-14 | Infinium Medical, Inc. | Vital Signs Monitor (CLEO2) |
| K253417 | 2026-08-12 | Masimo Corporation | Masimo Root Monitoring System 摘要 |
| K253196 | 2026-06-12 | Midmark Corporation | Midmark 800 Digital Vital Signs Device (1-300-0100, 摘要 |
| K253436 | 2026-04-30 | Cosinuss GmbH | c-med0 alpha 摘要 |
| K250135 | 2026-01-16 | Baxter Healthcare Corp/ Excel Medical | WAVE Clinical Platform (2.0.000) 摘要 |
| K241766 | 2025-08-27 | Fysicon BV | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) 摘要 |
| K242737 | 2025-06-06 | Empatica S.r.l. | Empatica Health Monitoring Platform; EmbracePlus; Em 摘要 |
| K241958 | 2025-02-14 | Ward 24/7 Aps | WARD-CSS (v1.2.x) 摘要 |
| K243146 | 2025-02-03 | Ihealth Labs, Inc. | iCare APP 摘要 |
| K241411 | 2024-12-20 | Welch Allyn, Inc. | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs 摘要 |
| K243216 | 2024-12-10 | Analog Devices | Sensinel Cardiopulmonary Management (CPM) System (AD |
| K233446 | 2024-09-27 | Amc Health | AMC Health CareConsole 摘要 |
| K240236 | 2024-09-24 | Happy Health, Inc. | Happy Ring Health Monitoring System 摘要 |
| K233354 | 2024-06-26 | Athena Gtx, Inc. | WVSM Pro (Series) (500-0030-XX) 摘要 |
| K232111 | 2024-06-25 | Laerdal Medical AS | NeoBeat, NeoBeat Mini 摘要 |
| K233810 | 2024-04-25 | Ge Medical Systems Information Technol | Portrait VSM 摘要 |
| K233133 | 2024-04-01 | Talis Clinical, LLC | Talis EMR with Talis +ACG (Talis EMR with +ACG) 摘要 |
| K234130 | 2024-03-20 | Ge Medical Systems Information Technol | Portrait Mobile Monitoring Solution consists of: 摘要 |
| K233038 | 2024-03-08 | Edan Instruments, Inc. | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3 摘要 |
| K231086 | 2023-12-22 | Analog Devices, Inc. | CPM System |
| K230457 | 2023-10-30 | Empatica S.r.l. | Empatica Health Monitoring Platform; EmbracePlus; Em 摘要 |
| K230881 | 2023-09-11 | Change Healthcare Israel , Ltd. | Change Healthcare Cardiology Hemodynamics 摘要 |
FDA 官方分类页： MWI
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。