ClearanceBrief
Panels › Cardiovascular › Product code MHX · Class 2

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

Regulation 870.1025

16510(k)s in 12 months (431 all time)
41recalls in 12 months (294 all time)
277recalls that name a 510(k)
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Top companies in MHX

Company510(k)sRecalls
GE Healthcare1052
Philips North America046
Ge Medical Systems Information Technologies348
Philips Medical Systems327
Spacelabs Healthcare433
Draeger Medical Systems, Inc.259
GE Healthcare Finland Oy1510
Philips Medizin Systeme Boeblingen GmbH250
Shenzhen Mindray Bio-Medical Electronics Co.230
Philips Electronics North America Corporation022
Decided510(k)Device and applicantCode
Dec 9, 2021K201764Infinity Acute Care System (IACS) Monitoring Solution
Draeger Medical Systems, Inc.
MHX
Oct 7, 2021K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Jul 16, 2021K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
Nihon Kohden Corporation, JP
MHX
Jan 23, 2021K202336Patient Monitor
Edan Instruments, Inc., CN
MHX
Jan 7, 2021K202405BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Nov 4, 2020K201941Monitor B125, Monitor B105
Ge Medical Systems Information Technologies, Inc.
MHX
Sep 18, 2020K201746Tempus Pro Patient Monitor
Remote Diagnostic Technologies Limited, GB
MHX
Sep 11, 2020K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Aug 28, 2020K200859Infinity M300
Draeger Medical Systems, Inc.
MHX
Jun 8, 2020K200015ePM Series Patient monitors
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
May 7, 2020K192972Patient Monitor
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Apr 2, 2020K192514Patient Monitor
Edan Instruments, Inc., CN
MHX
Mar 29, 2020K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
GE Healthcare
MHX
Jan 29, 2020K191323Carescape B850
GE Healthcare Finland Oy, FI
MHX
Jan 24, 2020K191249CARESCAPE B450
GE Healthcare Finland Oy, FI
MHX
Jan 21, 2020K191149CARESCAPE B650
GE Healthcare Finland Oy, FI
MHX
Dec 20, 2019K190008Carescape One
GE Healthcare
MHX
Dec 19, 2019K190939ZOLL Arrhythmia Management Sysyem
Zoll Manufacturing Corporation
MHX
Dec 13, 2019K191106C50 and C80 Multi-parameter Patient Monitor
Shenzhen Comen Medical Instruments Co.,Ltd, CN
MHX
Nov 19, 2019K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliV
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Oct 31, 2019K191769ePM Series Patient monitors
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Aug 6, 2019K183387M3290B Patient Information Center iX
Philips Medical Systems
MHX
Jul 10, 2019K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Dec 21, 2018K173036North-vision Multi-parameter Patient Monitor
North-Vision Tech., Inc., TW
MHX
Dec 10, 2018K182075BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVisi
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., TW
MHX
Nov 30, 2018K180482ZOLL Propaq M
ZOLL Medical Corporation
MHX
Nov 15, 2018K181831IntelliVue Multi-Measurement Module MMX
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Sep 4, 2018K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Sep 4, 2018K173765Surveyor Patient Monitor
Mortara Instrument, Inc.
MHX
Aug 16, 2018K173454Multi-parameter Patient Monitor, models C30
Shenzhen Comen Medical Instruments Co.,Ltd, CN
MHX
Jul 24, 2018K180017MX40 Release C.01
Philips Medical Systems
MHX
Jun 19, 2018K180472ViSi Mobile Monitoring System
Sotera Wireless, Inc.
MHX
May 11, 2018K172510µCor Heart Failure and Arrhythmia Management System
Zoll Manufacturing Corporation
MHX
Jan 10, 2018K173768Tempus Pro Patient Monitor
Remote Diagnostic Technologies , Ltd., GB
MHX
Dec 8, 2017K172966CMS-2000 Central Monitoring System
Advanced Instumentations, Inc.
MHX
Nov 15, 2017K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
MHX
Nov 9, 2017K172226MX40 Release B.07
Philips Medical Systems
MHX
Nov 1, 2017K171580Monitor B125, Monitor B105
Ge Medical Systems (China) Co., Ltd., CN
MHX
Oct 6, 2017K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extensio
Philips Medizin Systeme Boeblingen GmbH, DE
MHX
Aug 23, 2017K170876Passport Series Patient Monitors(Passport 12m, Passport 17m)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., TW
MHX
Jul 7, 2017K163584M3290B Philips IntelliVue Information Center iX
Philips Medical Systems
MHX
Jul 6, 2017K170567Tempus Pro Patient Monitor
Remote Diagnostic Technologies , Ltd., GB
MHX
Jun 30, 2017K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
Welch Allyn, Inc.
MHX
Jun 6, 2017K170155EK12 Algorithm
Ge Medical Systems Information Technologies, Inc.
MHX
May 24, 2017K170514Central Monitoring System
Guangdong Biolight Meditech Co., Ltd., CN
MHX
Apr 4, 2017K163459Nihon Kohden Vital Sign Telemeter
Nihon Kohden Corporation, JP
MHX
Feb 3, 2017K161056Telemetry Transmitter
Edan Instruments, Inc., CN
MHX
Jan 11, 2017K161517Mortara Surveyor Patient Monitor
Mortara Instrument, Inc.
MHX
Dec 22, 2016K160981Patient Monitor
Edan Instruments, Inc., CN
MHX
Sep 2, 2016K153707Nihon Kohden Vital Sign Telemeter
Nihon Kohden Corporation, JP
MHX

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