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MWI

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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)
22 件
其中 Summary 已存档
17 份,可直接下载
FDA 历史累计 510(k)
308 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(22 件)

数据窗口为最近三年。最新一件:2026-08-14。

510(k) 号批准日期申请人器械名称摘要
K2604382026-08-14Infinium Medical, Inc.Vital Signs Monitor (CLEO2)—
K2534172026-08-12Masimo CorporationMasimo Root Monitoring SystemFDA
K2531962026-06-12Midmark CorporationMidmark 800 Digital Vital Signs Device (1-300-0100, …PDF
K2534362026-04-30Cosinuss GmbHc-med0 alphaPDF
K2501352026-01-16Baxter Healthcare Corp/ Excel MedicalWAVE Clinical Platform (2.0.000)PDF
K2417662025-08-27Fysicon BVQMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)PDF
K2427372025-06-06Empatica S.r.l.Empatica Health Monitoring Platform; EmbracePlus; Em…PDF
K2419582025-02-14Ward 24/7 ApsWARD-CSS (v1.2.x)PDF
K2431462025-02-03Ihealth Labs, Inc.iCare APPPDF
K2414112024-12-20Welch Allyn, Inc.Welch Allyn Connex® Spot Monitor; 901058 Vital Signs…PDF
K2432162024-12-10Analog DevicesSensinel Cardiopulmonary Management (CPM) System (AD…—
K2334462024-09-27Amc HealthAMC Health CareConsolePDF
K2402362024-09-24Happy Health, Inc.Happy Ring Health Monitoring SystemPDF
K2333542024-06-26Athena Gtx, Inc.WVSM Pro (Series) (500-0030-XX)PDF
K2321112024-06-25Laerdal Medical ASNeoBeat, NeoBeat MiniPDF
K2338102024-04-25Ge Medical Systems Information Technol…Portrait VSMPDF
K2331332024-04-01Talis Clinical, LLCTalis EMR with Talis +ACG (Talis EMR with +ACG)PDF
K2341302024-03-20Ge Medical Systems Information Technol…Portrait™ Mobile Monitoring Solution consists of: …PDF
K2330382024-03-08Edan Instruments, Inc.Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3…PDF
K2310862023-12-22Analog Devices, Inc.CPM System—
K2304572023-10-30Empatica S.r.l.Empatica Health Monitoring Platform; EmbracePlus; Em…PDF
K2308812023-09-11Change Healthcare Israel , Ltd.Change Healthcare Cardiology Hemodynamics™FDA

其中 17 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。