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

DateFirm and productCodeLinked 510(k)
Jun 25, 2020Philips North America, LLC
IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
Open, Classified
MHXK151681
Jun 24, 2020GE Healthcare, LLC
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-2
Open, Classified
MHXK071073
Apr 23, 2020Philips North America, LLC
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
Terminated
MHXK041741
Apr 23, 2020Philips North America, LLC
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
Terminated
MHXK041741
Feb 18, 2020Edan Diagnostics
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardio
Terminated
MHXK161056
Oct 31, 2019Draegar Medical Systems, Inc.
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Open, Classified
MHXK093788
K113798
Oct 9, 2019Draegar Medical Systems, Inc.
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Open, Classified
MHXK130711
Oct 3, 2019Datascope Corp.
Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03
Terminated
MHXNone listed
Aug 30, 2019Spacelabs Healthcare, Inc.
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelab
Terminated
MHXK122146
Aug 23, 2019Philips North America, LLC
IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philip
Terminated
MHXK041741
Apr 29, 2019Philips North America, LLC
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Ce
Terminated
MHXK153702
Apr 19, 2019Philips North America, LLC
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Open, Classified
MHXK163649
Apr 19, 2019Philips North America, LLC
SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Open, Classified
MHXK163649
Apr 19, 2019Philips North America, LLC
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Open, Classified
MHXK163649
Apr 19, 2019Philips North America, LLC
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Open, Classified
MHXK163649
Apr 19, 2019Philips North America, LLC
SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Open, Classified
MHXK163649
Apr 19, 2019Philips North America, LLC
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Open, Classified
MHXK163649
Apr 19, 2019Philips North America, LLC
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Open, Classified
MHXK163649
Apr 19, 2019Philips North America, LLC
SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Open, Classified
MHXK163649
Feb 8, 2019Draegar Medical Systems, Inc.
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when us
Open, Classified
MHXK141756
Feb 8, 2019Draegar Medical Systems, Inc.
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the param
Open, Classified
MHXK152407
Jan 25, 2019Philips North America, LLC
Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the p
Terminated
MHXNone listed
Sep 11, 2018GE Healthcare, LLC
B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, a
Open, Classified
MHXK171580
Sep 11, 2018GE Healthcare, LLC
B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters
Open, Classified
MHXK143676
Sep 11, 2018GE Healthcare, LLC
B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameter
Open, Classified
MHXNone listed
Sep 11, 2018GE Healthcare, LLC
PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarm
Open, Classified
MHXK120598
K130584 +2
Sep 11, 2018GE Healthcare, LLC
PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multipl
Open, Classified
MHXK122253
Aug 31, 2018GE Healthcare, LLC
Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Open, Classified
MHXK030575
K033964 +1
Aug 31, 2018GE Healthcare, LLC
Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Open, Classified
MHXK012467
Aug 31, 2018GE Healthcare, LLC
Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Open, Classified
MHXK071073
Aug 31, 2018GE Healthcare, LLC
Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Open, Classified
MHXK051367
K073462
Aug 31, 2018GE Healthcare, LLC
Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Open, Classified
MHXK001359
K020290 +3
Aug 30, 2018Mindray DS USA, Inc. dba Mindray North America
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Terminated
MHXK162607
Jul 13, 2018Philips Electronics North America Corporation
Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the phy
Open, Classified
MHXK090483
Jul 13, 2018Philips Electronics North America Corporation
Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by hea
Open, Classified
MHXK080495
K123900
Jul 13, 2018Philips Electronics North America Corporation
Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parame
Open, Classified
MHXK163649
Jul 13, 2018Philips Electronics North America Corporation
Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults
Open, Classified
MHXK163649
Jul 13, 2018Philips Electronics North America Corporation
Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia o
Open, Classified
MHXK070588
Apr 6, 2018Philips Electronics North America Corporation
IntelliVue X3 Patient Monitor.
Terminated
MHXK171801
Mar 28, 2018Draegar Medical Systems, Inc.
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4
Terminated
MHXK113798
Mar 3, 2018Philips Electronics North America Corporation
Philips Network Firewall (Cisco ASA 5506), Model # 867098
Terminated
MHXK171801
Feb 21, 2018Draegar Medical Systems, Inc.
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 404909805445
Terminated
MHXK113798
Jan 3, 2018Philips Electronics North America Corporation
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 8671
Terminated
MHXK102495
K143057
Dec 20, 2017Philips Electronics North America Corporation
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Terminated
MHXK112652
Oct 16, 2017Fukuda Denshi Co., Ltd.
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of
Completed
MHXK134046
Oct 4, 2017Draegar Medical Systems, Inc.
INFINITY DUAL HEMO MCable Pod
Terminated
MHXK113798
Aug 23, 2017Philips Electronics North America Corporation
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use
Open, Classified
MHXK150310
K150975
Jul 13, 2017GE Medical Systems Information Technologies, Inc.
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic p
Terminated
MHXK071073
Jun 13, 2017Philips Electronics North America Corporation
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105,
Terminated
MHXK062271
Jun 6, 2017Draegar Medical Systems, Inc.
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Terminated
MHXK113798

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