Philips Intellivue MP5 Patient Monitor

Q: What is the product code of K083228?

The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.

FDA 510(k) K083228 · Philips Medizin Systeme Boblingen GmbH

Substantially Equivalent

510(k) numberK083228

Submission

Device name: Philips Intellivue MP5 Patient Monitor
Applicant: Philips Medizin Systeme Boblingen GmbH
Boeblingen, DE
Received: November 3, 2008
Decision date: November 24, 2008
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1025
Specialty: Cardiovascular

Other 510(k)s with product code MHX

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K260656	Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional	GE Healthcare Finland Oy	09/01/2026SE
K260343	Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional	GE Healthcare Finland Oy	08/28/2026SE
K260579	Infinity® Acute Care System (IACS) VG8.1MHX · Traditional	Draeger Medical Systems, Inc.	08/20/2026SE
K251508	Telemetry Monitor (iT30, iT50)MHX · Traditional	Edan Instruments, Inc.	08/06/2026SE
K253277	Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional	Ge Medical Systems Information Technologies, Inc.	07/24/2026SE
K254209	Radius VSM and AccessoriesMHX · Traditional	Masimo Corporation	06/04/2026SE
K252840	M12 Telemetry SystemMHX · Traditional	Global Instrumentation, LLC	05/29/2026SE
K260098	ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	05/20/2026SE
K250349	Vista CMSMHX · Traditional	Shanghai Draeger Medical Instrument Co., Ltd.	04/24/2026SE
K253170	uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	04/16/2026SE

More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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K113657	Intellivue Patient MonitorMHX · Traditional	03/22/2012SE
K102958	Philips Avalon Fetal MonitorHGM · Traditional	03/18/2011SE
K102562	Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…MHX · Special	10/21/2010SE
K090360	Philips M3001A Multi Measurement ServerDQA · Special	05/04/2009SE
K060541	The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsMHX · Special	03/24/2006SE
K042845	The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsMSX · Special	11/12/2004SE
K032858	The Philips Intellivue MP40, MP50, MP60, MP70,AND MP90 Patient Monitors, Release B.O.DSI · Special	10/10/2003SE
K031481	The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release A.20MHX · Special	05/29/2003SE

Questions and answers

When was Philips Intellivue MP5 Patient Monitor cleared by the FDA?

Philips Intellivue MP5 Patient Monitor (K083228) received a 510(k) decision of Substantially Equivalent on November 24, 2008, 21 days after the submission was received.

What is the product code of K083228?

The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.