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)
Top companies in MHX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2020 | Philips North America, LLC IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173 Open, Classified |
MHX | K151681 |
| Jun 24, 2020 | GE 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 |
MHX | K071073 |
| Apr 23, 2020 | Philips North America, LLC TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System
Codes 453564007261, 453564007271, 453564007281, 989803196951 Terminated |
MHX | K041741 |
| Apr 23, 2020 | Philips North America, LLC TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861 Terminated |
MHX | K041741 |
| Feb 18, 2020 | Edan 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 |
MHX | K161056 |
| Oct 31, 2019 | Draegar 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 |
MHX | K093788 K113798 |
| Oct 9, 2019 | Draegar 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 |
MHX | K130711 |
| Oct 3, 2019 | Datascope 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 |
MHX | None listed |
| Aug 30, 2019 | Spacelabs 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 |
MHX | K122146 |
| Aug 23, 2019 | Philips 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 |
MHX | K041741 |
| Apr 29, 2019 | Philips 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 |
MHX | K153702 |
| Apr 19, 2019 | Philips North America, LLC SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified |
MHX | K163649 |
| Apr 19, 2019 | Philips North America, LLC SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified |
MHX | K163649 |
| Apr 19, 2019 | Philips North America, LLC SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified |
MHX | K163649 |
| Apr 19, 2019 | Philips North America, LLC SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified |
MHX | K163649 |
| Apr 19, 2019 | Philips North America, LLC SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified |
MHX | K163649 |
| Apr 19, 2019 | Philips North America, LLC SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified |
MHX | K163649 |
| Apr 19, 2019 | Philips North America, LLC SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified |
MHX | K163649 |
| Apr 19, 2019 | Philips North America, LLC SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified |
MHX | K163649 |
| Feb 8, 2019 | Draegar 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 |
MHX | K141756 |
| Feb 8, 2019 | Draegar 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 |
MHX | K152407 |
| Jan 25, 2019 | Philips 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 |
MHX | None listed |
| Sep 11, 2018 | GE 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 |
MHX | K171580 |
| Sep 11, 2018 | GE 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 |
MHX | K143676 |
| Sep 11, 2018 | GE 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 |
MHX | None listed |
| Sep 11, 2018 | GE 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 |
MHX | K120598 K130584 +2 |
| Sep 11, 2018 | GE 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 |
MHX | K122253 |
| Aug 31, 2018 | GE Healthcare, LLC Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Open, Classified |
MHX | K030575 K033964 +1 |
| Aug 31, 2018 | GE Healthcare, LLC Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Open, Classified |
MHX | K012467 |
| Aug 31, 2018 | GE Healthcare, LLC Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Open, Classified |
MHX | K071073 |
| Aug 31, 2018 | GE Healthcare, LLC Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Open, Classified |
MHX | K051367 K073462 |
| Aug 31, 2018 | GE Healthcare, LLC Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Open, Classified |
MHX | K001359 K020290 +3 |
| Aug 30, 2018 | Mindray DS USA, Inc. dba Mindray North America Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 Terminated |
MHX | K162607 |
| Jul 13, 2018 | Philips 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 |
MHX | K090483 |
| Jul 13, 2018 | Philips 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 |
MHX | K080495 K123900 |
| Jul 13, 2018 | Philips 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 |
MHX | K163649 |
| Jul 13, 2018 | Philips 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 |
MHX | K163649 |
| Jul 13, 2018 | Philips 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 |
MHX | K070588 |
| Apr 6, 2018 | Philips Electronics North America Corporation IntelliVue X3 Patient Monitor. Terminated |
MHX | K171801 |
| Mar 28, 2018 | Draegar 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 |
MHX | K113798 |
| Mar 3, 2018 | Philips Electronics North America Corporation Philips Network Firewall (Cisco ASA 5506), Model # 867098 Terminated |
MHX | K171801 |
| Feb 21, 2018 | Draegar 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 |
MHX | K113798 |
| Jan 3, 2018 | Philips 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 |
MHX | K102495 K143057 |
| Dec 20, 2017 | Philips Electronics North America Corporation Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility. Terminated |
MHX | K112652 |
| Oct 16, 2017 | Fukuda 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 |
MHX | K134046 |
| Oct 4, 2017 | Draegar Medical Systems, Inc. INFINITY DUAL HEMO MCable Pod Terminated |
MHX | K113798 |
| Aug 23, 2017 | Philips 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 |
MHX | K150310 K150975 |
| Jul 13, 2017 | GE 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 |
MHX | K071073 |
| Jun 13, 2017 | Philips 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 |
MHX | K062271 |
| Jun 6, 2017 | Draegar Medical Systems, Inc. Draeger Medical Systems Infinity Acute Care System (M540)
Catalog Numbers: MK31501/MK31701/MK31722 Terminated |
MHX | K113798 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.