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) |
|---|---|---|---|
| Aug 15, 2011 | Spacelabs Healthcare, Llc Spacelabs Medical elance Vital Signs Monitor, Model 93300.
The Spacelabs elance Vital Signs Monitor and elance Central Station is a prescription device intended for use by healthcare professionals in Terminated |
MHX | K093501 |
| Aug 2, 2011 | Spacelabs Healthcare, Llc Vital Sign elance Monitor, Model 93300
Spacelabs Healthcare, Llc.
A vital signs patient monitor with arrhythmia detection. Terminated |
MHX | K093501 |
| Jun 20, 2011 | Spacelabs Healthcare, Llc The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's vent Terminated |
MHX | K031124 |
| Jun 17, 2011 | Philips Healthcare Inc. Philips SureSigns VM Series Patient Monitors:
VM4, VM6, VM 8:
Model Part Numbers
VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971
VM6 863064, 863065, 453564024421, 453564022001, 453 Terminated |
MHX | K101067 |
| May 19, 2011 | Philips Healthcare Inc. Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center
The intended use of the Information Center Software is to display physiologic waves, para Terminated |
MHX | K081983 |
| May 3, 2011 | Spacelabs Healthcare, Llc Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496.
Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-0 Terminated |
MHX | K102422 |
| Apr 8, 2011 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B850
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare f Terminated |
MHX | None listed |
| Apr 8, 2011 | 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 intrahospital transport within a professional healthcare f Terminated |
MHX | K102239 |
| Apr 8, 2011 | GE Healthcare, LLC GE
The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE M Terminated |
MHX | K092027 |
| Mar 3, 2011 | GE Healthcare, LLC GE Healthcare, ApexPro Telemetry System
The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and moni Terminated |
MHX | K080251 |
| Jan 27, 2011 | Philips Healthcare Inc. Physiological Monitoring, Patient Monitor
M31250 Information Center Local Database
Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PA Terminated |
MHX | K081983 |
| Nov 15, 2010 | GE Healthcare, LLC Power supply boards on Dash 3000, 4000 and 5000 Monitors.
GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223. Terminated |
MHX | K073462 |
| Nov 15, 2010 | GE Healthcare, LLC GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module. Terminated |
MHX | K071073 |
| Aug 26, 2010 | Draeger Medical Systems, Inc. Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Terminated |
MHX | K070566 |
| Aug 26, 2010 | Draeger Medical Systems, Inc. Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Terminated |
MHX | K070566 |
| Aug 25, 2010 | GE Healthcare, LLC CARESCAPE MONITOR B850
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. Terminated |
MHX | K092027 |
| Aug 10, 2010 | Philips Healthcare Inc. Philips Intellivue Patient Monitor Model MP70 (M8007A) Terminated |
MHX | K093268 |
| Aug 10, 2010 | Philips Healthcare Inc. Philips Intellivue Patient Monitor Model MP60 (M8005A) Terminated |
MHX | K093268 |
| Jun 11, 2010 | Ge Healthcare, Llc GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1
The CARESCAPE " Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within Terminated |
MHX | None listed |
| Jun 10, 2010 | Mindray DS USA, Inc., dba Datascope Patient Monitoring Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430.
Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of var Terminated |
MHX | K091834 |
| Dec 29, 2009 | Draeger Medical, Inc. Delta/Delta XL Monitors with Omega S Package Terminated |
MHX | K070566 |
| Nov 23, 2009 | Philips Healthcare Inc. SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predictive Temperature only; SPo2 only; SPo2 and Recorder only; SPo2 and Predictive Temperature only; or Terminated |
MHX | K090483 |
| Nov 23, 2009 | Philips Healthcare Inc. SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM monitors at 1 time
Part number: 863069,863070,863071,863072,863073,863074,453564041251,453564041261,
45 Terminated |
MHX | K070588 |
| Nov 23, 2009 | Philips Healthcare Inc. SureSigns Patient Monitors (VM3, VM4. VM6. VM8):
VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display
VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedsi Terminated |
MHX | K090483 |
| Sep 11, 2009 | Spacelabs Healthcare, Incorporated Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The Terminated |
MHX | K090556 |
| Jun 1, 2009 | GE Healthcare GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring. Terminated |
MHX | K032369 |
| May 27, 2009 | Mindray DS USA, Inc., dba Datascope Patient Monitoring Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7.
Datascope Patient Monitoring
Intended for use in a fixed location, in the healthcare fa Terminated |
MHX | K031760 |
| Sep 16, 2008 | CAS Medical Systems, Inc. 740 Series Multiparameter Monitor Software Version 3.0
Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740 Terminated |
MHX | K033048 |
| Sep 16, 2008 | Philips Medical Systems Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, reco Terminated |
MHX | K052707 |
| Jan 17, 2008 | Datascope Corporation Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ Terminated |
MHX | None listed |
| Dec 11, 2007 | Philips Medical Systems Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J Terminated |
MHX | K062271 |
| Sep 5, 2007 | Philips Medical Systems Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station
Models: M3145, M3150, M3154, M3155, M3169 Terminated |
MHX | K062271 |
| Dec 19, 2006 | Draeger Medical, Inc. Infinity Docking Station (IDS) (transportable patient monitor) Repair Kit, part number 7262814 Terminated |
MHX | None listed |
| Dec 19, 2006 | Draeger Medical, Inc. Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375. Terminated |
MHX | K053484 |
| Dec 19, 2006 | Draeger Medical, Inc. Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375. Terminated |
MHX | K060039 |
| Oct 21, 2006 | Ge Healthcare ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver ac Terminated |
MHX | K033365 |
| Oct 20, 2006 | Ge Healthcare GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The re Terminated |
MHX | K032369 |
| Jan 24, 2006 | Datascope Corp Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. Terminated |
MHX | K031760 |
| Jul 20, 2004 | GE Medical Systems Information Technologies Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEX Terminated |
MHX | None listed |
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda Cardiocap/5 Patient Monitors Terminated |
MHX | K012837 K992323 |
| Dec 18, 2003 | General Electric Medical Systems Information Technology Solar 9500 Information Monitor with software version 3A. Terminated |
MHX | K030575 |
| Aug 21, 2003 | Hill-Rom Co., Inc. Integris Monitor Arm, model P997-03. Terminated |
MHX | None listed |
| Aug 21, 2003 | Hill-Rom Co., Inc. Integris Monitor Arm, model P997-01. Terminated |
MHX | None listed |
| Aug 21, 2003 | Hill-Rom Co., Inc. Integris Monitor Arm; model P997-04 Terminated |
MHX | None listed |
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