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)
36recalls 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)
May 16, 2014Philips 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
MHXK110622
May 13, 2014Mindray 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
MHXK092449
Mar 11, 2014GE 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
MHXK092027
K102239 +2
Mar 7, 2014Mindray 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
MHXK031760
Mar 6, 2014GE 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
MHXK071073
Feb 14, 2014GE Healthcare, LLC
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
Terminated
MHXK073462
K992929
Feb 4, 2014GE 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
MHXK092027
Jan 30, 2014Spacelabs 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
MHXK121480
Jan 28, 2014GE 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
MHXK092027
K102239
Jan 22, 2014GE 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
MHXK011000
K053121 +1
Jan 22, 2014GE 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
MHXK071073
Jan 22, 2014GE 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
MHXK073462
Jan 14, 2014GE 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
MHXK071073
Jan 10, 2014Draeger Medical Systems, Inc.
Draeger Infinity Acute Care System Monitoring Solution
Terminated
MHXK113798
Jan 9, 2014GE Healthcare, LLC
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
Terminated
MHXK071073
Dec 12, 2013GE 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
MHXK120598
K122253 +1
Nov 25, 2013Mindray 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
MHXK102004
Nov 18, 2013Spacelabs 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
MHXK120616
Nov 8, 2013Spacelabs Healthcare, Llc
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
Terminated
MHXK120616
Sep 19, 2013GE 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
MHXK102239
Sep 16, 2013GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Terminated
MHXK092027
Aug 28, 2013GE 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
MHXK053121
Aug 28, 2013GE 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
MHXK071073
Aug 28, 2013GE 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
MHXK073462
Jul 20, 2013Philips 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
MHXK041741
Jun 21, 2013GE 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
MHXK092027
Mar 11, 2013Draeger Medical, Inc.
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Terminated
MHXK093788
K113798
Feb 14, 2013GE 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
MHXK102239
Feb 14, 2013GE 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
MHXK073462
Feb 13, 2013GE Healthcare, LLC
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
Terminated
MHXK073462
Dec 17, 2012Mindray 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
MHXK102004
Dec 16, 2012GE 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
MHXK073462
Dec 14, 2012GE 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
MHXK071073
Dec 11, 2012Mindray 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
MHXK092449
Dec 10, 2012Philips 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
MHXK081983
K102495
Nov 20, 2012Spacelabs 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
MHXK120616
Nov 5, 2012Spacelabs 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
MHXK112962
Sep 14, 2012Zoe 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
MHXK093802
Aug 28, 2012Mindray 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
MHXK102004
Jul 16, 2012Spacelabs 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
MHXK112962
Jul 16, 2012GE Healthcare, LLC
GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
Terminated
MHXK042642
Jun 5, 2012Spacelabs 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
MHXK112962
Mar 1, 2012Philips 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
MHXK110622
Nov 23, 2011Draeger 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
MHXK070566
Nov 22, 2011Draeger 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
MHXK093788
Aug 25, 2011GE 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
MHXK073462
Aug 22, 2011Draeger 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
MHXK070566
Aug 22, 2011Draeger 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
MHXK070566
Aug 18, 2011Spacelabs 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
MHXK972282
Aug 17, 2011Spacelabs 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
MHXK102422

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