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)
May 4, 2017Philips Electronics North America Corporation
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
Terminated
MHXK122439
Apr 28, 2017Mindray DS USA, Inc. dba Mindray North America
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Terminated
MHXK152902
Mar 28, 2017Draegar Medical Systems, Inc.
Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are inte
Terminated
MHXK152407
Mar 28, 2017Draegar Medical Systems, Inc.
Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where p
Terminated
MHXK152407
Mar 28, 2017Draegar Medical Systems, Inc.
Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where pat
Terminated
MHXK152407
Mar 20, 2017Nihon Kohden America Inc
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
Terminated
MHXK151080
Jan 17, 2017Philips Electronics North America Corporation
Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, paramete
Terminated
MHXK160951
Nov 2, 2016Spacelabs Healthcare Inc
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthc
Terminated
MHXK122146
Sep 26, 2016Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Terminated
MHXK141156
Sep 26, 2016Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Terminated
MHXK122146
Sep 19, 2016Philips Electronics North America Corporation
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part
Terminated
MHXK113125
Sep 19, 2016Philips Electronics North America Corporation
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 4535642
Terminated
MHXK113125
Sep 19, 2016Philips Electronics North America Corporation
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262
Terminated
MHXK113125
Sep 8, 2016Mindray DS USA, Inc. dba Mindray North America
TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
Terminated
MHXK150632
Jul 26, 2016Philips Electronics North America Corporation
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor
Terminated
MHXK131872
K141015 +1
Jun 23, 2016Mindray DS USA, Inc. dba Mindray North America
Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12
Terminated
MHXK143195
Jun 23, 2016Edan Diagnostics
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the
Terminated
MHXK110922
K113623 +2
Mar 28, 2016Spacelabs Healthcare Inc
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Terminated
MHXK141156
Mar 9, 2016Mindray DS USA, Inc. dba Mindray North America
Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monito
Terminated
MHXK150882
Feb 26, 2016Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient mo
Terminated
MHXK122146
Feb 23, 2016Philips Electronics North America Corporation
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Terminated
MHXK102495
Feb 23, 2016Philips Electronics North America Corporation
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Terminated
MHXK102495
Feb 23, 2016Philips Electronics North America Corporation
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Terminated
MHXK102495
Jan 29, 2016Mindray DS USA, Inc. dba Mindray North America
Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Pa
Terminated
MHXK150082
Jan 16, 2016Fukuda Denshi USA, Inc.
Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.
Terminated
MHXK134046
Jan 4, 2016Philips Electronics North America Corporation
Philips IntelliVue Module Measurement X2 Model: M3002A
Terminated
MHXK150310
Jan 4, 2016Philips Electronics North America Corporation
Philips IntelliVue Measurement Module X1 Model: M3001A
Terminated
MHXK150310
Dec 4, 2015Philips Medical Systems, Inc.
Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended us
Terminated
MHXK102495
Sep 4, 2015Mindray DS USA, Inc. dba Mindray North America
Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological
Terminated
MHXK092449
May 26, 2015Mindray DS USA, Inc. dba Mindray North America
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System
Terminated
MHXK142601
May 13, 2015Spacelabs Healthcare Inc
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports i
Terminated
MHXK120616
May 12, 2015GE Healthcare
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Terminated
MHXK092027
K102239 +3
Apr 29, 2015Nihon Kohden America Inc
Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital
Terminated
MHXK023475
Mar 16, 2015Mindray DS USA, Inc. dba Mindray North America
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Terminated
MHXK091834
Feb 24, 2015Spacelabs Healthcare Inc
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated b
Terminated
MHXK120616
Feb 24, 2015Spacelabs Healthcare Inc
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, an
Terminated
MHXK112962
Dec 19, 2014Mindray DS USA, Inc. dba Mindray North America
DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for
Terminated
MHXK092449
Oct 22, 2014Mortara Instrument, Inc
Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood press
Terminated
MHXK123556
Oct 21, 2014Philips Medical Systems, Inc.
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intend
Terminated
MHXK122439
K131913
Oct 21, 2014Mindray DS USA, Inc. dba Mindray North America
Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Terminated
MHXK132026
Oct 9, 2014GE Healthcare, LLC
GE Healthcare Carescape Patient Data Module
Terminated
MHXK071073
Sep 25, 2014Spacelabs Healthcare Inc
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option
Terminated
MHXK102422
Sep 4, 2014Spacelabs Healthcare Inc
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Terminated
MHXK121480
Jul 24, 2014GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
Terminated
MHXK102239
Jul 21, 2014GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Terminated
MHXK092027
K131223 +3
Jul 16, 2014Mindray DS USA, Inc. dba Mindray North America
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Dr
Terminated
MHXNone listed
Jul 2, 2014Nihon Kohden America Inc
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Terminated
MHXK102376
Jun 23, 2014Spacelabs Healthcare Inc
Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors vi
Terminated
MHXK120616
Jun 11, 2014Philips Healthcare Inc.
Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
Terminated
MHXK102495
Jun 10, 2014Philips Medical Systems, Inc.
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Terminated
MHXK103646
K113125

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