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MHX

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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)
28 件
其中 Summary 已存档
23 份,可直接下载
FDA 历史累计 510(k)
429 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)(28 件)

数据窗口为最近三年。最新一件:2026-08-28。

510(k) 号批准日期申请人器械名称摘要
K2603432026-08-28GE Healthcare Finland OyCarescape Canvas 1000; Carescape Canvas Smart Displa…PDF
K2605792026-08-20Draeger Medical Systems, Inc.Infinity® Acute Care System (IACS) – VG8.1PDF
K2515082026-08-06Edan Instruments, Inc.Telemetry Monitor (iT30, iT50)PDF
K2532772026-07-24Ge Medical Systems Information Technol…Monitor B105M; Monitor B125M; Monitor B155M; Monitor…FDA
K2542092026-06-04Masimo CorporationRadius VSM and AccessoriesFDA
K2528402026-05-29Global Instrumentation, LLCM12 Telemetry SystemPDF
K2600982026-05-20Shenzhen Mindray Bio-Medical Electroni…ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/G…FDA
K2503492026-04-24Shanghai Draeger Medical Instrument Co…Vista CMSPDF
K2531702026-04-16Shenzhen Mindray Bio-Medical Electroni…uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150…PDF
K2522502026-04-10Shanghai Draeger Medical Instrument Co…Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US…PDF
K2527262026-02-06Philips Medizin Systeme Boeblingen Gmb…IntelliVue Multi-Measurement Module X3 (867030); Int…PDF
K2525892026-01-09AliveCor, Inc.Corvair MonzaPDF
K2508542025-12-17Shenzhen Comen Medical Instruments Co.…Multi-parameter Patient Monitor (N10); Multi-parame…PDF
K2517022025-11-10Philips Medizin Systeme Böblingen GmbHIntelliVue Patient Monitor MX750; IntelliVue Patient…PDF
K2511462025-10-17Philips Medizin Systeme Boeblingen Gmb…IntelliVue Patient monitors MX400, MX450, MX500, MX5…PDF
K2504532025-09-02Philips Medizin Systeme Böblingen GmbHIntelliVue Patient Monitor 6100 (6100); IntelliVue P…PDF
K2501792025-07-29Edan Instruments, Inc.Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)PDF
K2425622025-07-09Ge Medical Systems Information Technol…Monitor B105M; Monitor B125M; Monitor B155M; Monitor…FDA
K2507572025-05-29Masimo CorporationRadius VSM and AccessoriesPDF
K2429622025-05-05Philips Medizin Systeme Böblingen GmbHTelemetry Monitor 5500 Release 4.0 (867232)PDF
K2403122024-08-01Draeger Medical Systems, Inc.Infinity CentralStation WidePDF
K2403202024-06-28Edan Instruments, Inc.Patient Monitor (RespArray)PDF
K2310102024-06-07AliveCor, Inc.CorvairPDF
K2329622024-04-19Edan Instruments, Inc.Patient Monitor (iX10, iX12, iX15)PDF
K2326942024-02-05Edan Instruments, Inc.Central Monitoring System (MFM-CMS)FDA
K2316712023-12-19Philips Medizin Systeme Boeblingen Gmb…IntelliVue Patient Monitor MX750 (866471), IntelliVu…PDF
K2306042023-11-22Philips Medizin Systeme Boeblingen Gmb…IntelliVue Patient Monitor MX100 (867033), IntelliVu…PDF
K2314772023-10-17Draeger Medical Systems, Inc.Infinity CentralStation Wide, Infinity M300, Infinit…PDF

其中 23 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: 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。