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)
36recalls in 12 months (294 all time)
277recalls that name a 510(k)
Top companies in MHX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2014 | Philips Medical Systems, Inc. Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters. Terminated |
MHX | K110622 |
| May 13, 2014 | Mindray DS USA, Inc. dba Mindray North America DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhyth Terminated |
MHX | K092449 |
| Mar 11, 2014 | GE Healthcare, LLC GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850.
K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and Terminated |
MHX | K092027 K102239 +2 |
| Mar 7, 2014 | Mindray DS USA, Inc. dba Mindray North America Panaroma Central Station
Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for da Terminated |
MHX | K031760 |
| Mar 6, 2014 | GE Healthcare, LLC GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled.
The Solar 8000i with Patient Data Module / Transp Terminated |
MHX | K071073 |
| Feb 14, 2014 | GE Healthcare, LLC GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station. Terminated |
MHX | K073462 K992929 |
| Feb 4, 2014 | GE Healthcare, LLC CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.
Product Usage: The CARESCAPE Monitor B850 is inte Terminated |
MHX | K092027 |
| Jan 30, 2014 | Spacelabs Healthcare, Llc ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C.
Model 96281 is intended for use with either adult or neonatal patient
populations in a hospital environment. Terminated |
MHX | K121480 |
| Jan 28, 2014 | GE Healthcare, LLC GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850.
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within Terminated |
MHX | K092027 K102239 |
| Jan 22, 2014 | GE Healthcare, LLC GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonata Terminated |
MHX | K011000 K053121 +1 |
| Jan 22, 2014 | GE Healthcare, LLC SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquis Terminated |
MHX | K071073 |
| Jan 22, 2014 | GE Healthcare, LLC GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
K073462: The Dash Terminated |
MHX | K073462 |
| Jan 14, 2014 | GE Healthcare, LLC GE Healthcare Carescape Patient Data Module
The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients dur Terminated |
MHX | K071073 |
| Jan 10, 2014 | Draeger Medical Systems, Inc. Draeger Infinity Acute Care System Monitoring Solution Terminated |
MHX | K113798 |
| Jan 9, 2014 | GE Healthcare, LLC SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Terminated |
MHX | K071073 |
| Dec 12, 2013 | GE Healthcare, LLC HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40
K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for mo Terminated |
MHX | K120598 K122253 +1 |
| Nov 25, 2013 | Mindray DS USA, Inc. dba Mindray North America Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
Product Usage:
The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare p Terminated |
MHX | K102004 |
| Nov 18, 2013 | Spacelabs Healthcare, Llc Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms.
The qube is intended for use under the direct supervision of a licensed h Terminated |
MHX | K120616 |
| Nov 8, 2013 | Spacelabs Healthcare, Llc Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms. Terminated |
MHX | K120616 |
| Sep 19, 2013 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B650.
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare Terminated |
MHX | K102239 |
| Sep 16, 2013 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B850.
Intended for use in multiple areas within a professional healthcare facility. Terminated |
MHX | K092027 |
| Aug 28, 2013 | GE Healthcare, LLC GE Healthcare, TRAM MODULE, High-acuity patient monitoring.
Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neon Terminated |
MHX | K053121 |
| Aug 28, 2013 | GE Healthcare, LLC SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
(Marketed As GE Healthcare CARESCAPE Patient Data Module)
Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acqu Terminated |
MHX | K071073 |
| Aug 28, 2013 | GE Healthcare, LLC GE Healthcare, Dash 3000, Dash 4000 and Dash 5000.
Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. Terminated |
MHX | K073462 |
| Jul 20, 2013 | Philips Healthcare Inc. Radiohead Access Point 1.4 GHz Radiohead Access Point
Firmware versions: C.00.04 & C.00.05
Part Number: 989803171211
Product Usage:
IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless Terminated |
MHX | K041741 |
| Jun 21, 2013 | GE Healthcare, LLC CARESCAPE Monitor B850
Product Usage:
The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on Terminated |
MHX | K092027 |
| Mar 11, 2013 | Draeger Medical, Inc. Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo)
Physiological patient monitoring system. Terminated |
MHX | K093788 K113798 |
| Feb 14, 2013 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B650.
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare Terminated |
MHX | K102239 |
| Feb 14, 2013 | GE Healthcare, LLC GE Healthcare, Dash Port 2 Docking Station.
Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, Terminated |
MHX | K073462 |
| Feb 13, 2013 | GE Healthcare, LLC GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. Terminated |
MHX | K073462 |
| Dec 17, 2012 | Mindray DS USA, Inc. d.b.a. Mindray North America Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China
Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China
One prod Terminated |
MHX | K102004 |
| Dec 16, 2012 | GE Healthcare, LLC GE Healthcare, Dash 3000/4000/5000.
The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is t Terminated |
MHX | K073462 |
| Dec 14, 2012 | GE Healthcare, LLC GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiolo Terminated |
MHX | K071073 |
| Dec 11, 2012 | Mindray DS USA, Inc. d.b.a. Mindray North America DPM 6/7 Patient Monitor
Manufactured in China for :
Mindray DS USA, Inc.
800 MacArthur Blvd.
Mahwah, NJ 07430 USA.
Intended to be used for monitoring, displaying, reviewing, storing and alarming of Terminated |
MHX | K092449 |
| Dec 10, 2012 | Philips Healthcare Inc. Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX
The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, Terminated |
MHX | K081983 K102495 |
| Nov 20, 2012 | Spacelabs Healthcare, Llc qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD displa Terminated |
MHX | K120616 |
| Nov 5, 2012 | Spacelabs Healthcare, Llc The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal -- Terminated |
MHX | K112962 |
| Sep 14, 2012 | Zoe Medical Incorporated Spacelabs Ultraview DM3 Monitor
Model Number: 91330-NT
The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is int Terminated |
MHX | K093802 |
| Aug 28, 2012 | Mindray DS USA, Inc. d.b.a. Mindray North America V Series Patient Monitors; Mindray DS USA, Inc.
Product Usage:
The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indicati Terminated |
MHX | K102004 |
| Jul 16, 2012 | Spacelabs Healthcare, Llc Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms.
The Spacelabs Healthcare Xprezzon Bedside Monitor is Terminated |
MHX | K112962 |
| Jul 16, 2012 | GE Healthcare, LLC GE Healthcare, Invasive Blood Pressure Care Cables.
Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004. Terminated |
MHX | K042642 |
| Jun 5, 2012 | Spacelabs Healthcare, Llc Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393.
The Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parame Terminated |
MHX | K112962 |
| Mar 1, 2012 | Philips Healthcare Inc. Philips IntelliVue Patient Monitors:
The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neona Terminated |
MHX | K110622 |
| Nov 23, 2011 | Draeger Medical, Inc. Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms). Terminated |
MHX | K070566 |
| Nov 22, 2011 | Draeger Medical, Inc. Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution
Networked solution/system used to monitor patients' vital signs and therapy, control alarms, Terminated |
MHX | K093788 |
| Aug 25, 2011 | GE Healthcare, LLC GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors
The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use Terminated |
MHX | K073462 |
| Aug 22, 2011 | Draeger Medical Systems, Inc. Infinity Gamma X XL Portable Patient Monitor.
Draeger Medical Systems, Inc.
Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applica Terminated |
MHX | K070566 |
| Aug 22, 2011 | Draeger Medical Systems, Inc. Infinity Delta Portable Patient Monitor.
Draeger Medical Systems, Inc.
Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications Terminated |
MHX | K070566 |
| Aug 18, 2011 | Spacelabs Healthcare, Llc Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option.
Product Usage: Spacelabs Medical PCIS patient monitors passively di Terminated |
MHX | K972282 |
| Aug 17, 2011 | Spacelabs Healthcare, Llc Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, & 91393 are sold with with Perioperative Mode (op Terminated |
MHX | K102422 |
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