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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP5T, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment.

The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX800 IntelliVue Patient Monitors that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules. All monitors share the same system architecture and exactly the same software is executed on each monitor. The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG, invasive and non-invasive pressure, etc., generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to central stations via the IntelliVue Clinical Network. The subject modification is the introduction of software revision H.03 for the entire IntelliVue Patient Monitors family.

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of of multiple physiological parameters of adults, pediatrics and neonates healthcare facilities. The MP20, MP30, MP40 and MP50 are in additionally intended for use in transport situations within healthcare facilities. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCC2) is restricted to neonatal patients only.

The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release D.03 software for the IntelliVue patient monitor devices, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients. Intended for monitoring, recording and alarming of of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments. EASI 12-lead ECG is only for use on adult and pediatric patients. ST Seqment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02/tcpCO2) is restricted to neonatal patients only.

The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor. The modification is the introduction of Release B.1.1 software for the IntelliVue patient monitor devices, MP20, MP30, MP40, MP50 interfacing the Gas Analyzer model M1013A EGM (K041956). The modified devices have the same technological characteristics as the legally marketed predicate devices.

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. EASI 12-lead ECG is only for use on adult and pediatric patients. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.

The Philips MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor.

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. EASI 12-lead ECG is only for use on adult and pediatric patients. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

The Philips MP60, MP70, and MP90 IntelliVue Patient Monitor. The modification is updated software of the Philips Medical System MP60, MP70 and MP90 IntelliVue patient monitor devices.

The Component Monitoring System and V24/V26 family of patient monitors is intended for the monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by healthcare professionals whenever there is a need for monitoring the physiologic parameters of adult, neonatal, and pediatric patients.

The modification in this submission is the addition of an alternate blood analysis module to the current plug-in i-STAT module as a component to the CMS and V24/V26 family of patient monitors. The proposed M3560A Blood Analysis Portal System is substantially equivalent to the Diametrics IRMA Blood Analysis System but provides a plug-in interface instead of an RS232 interface connection. Only Diametrics analysis cartridges (IRMA cartridges) are used with this module. The new M3560A Blood Analysis Portal System is also smaller than the current Diametrics IRMA Blood Analysis System and does not operate via battery power.