Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450

Q: What is the product code of K130849?

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) K130849 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

Substantially Equivalent

510(k) numberK130849

Submission

Device name: Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450
Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Boeblingen, Baden-Wuerttemberg, DE
Received: March 26, 2013
Decision date: June 14, 2013
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

510(k)	Device	Applicant	Decision
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.

510(k)	Device	Decision
K141015	Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…MHX · Special	05/19/2014SE
K132320	Intellivue CL Respiration PodBZQ · Traditional	03/26/2014SE
K131872	Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550MHX · Special	10/17/2013SE
K131829	Intellivue Patient MonitorMHX · Special	08/16/2013SE
K120366	Intellivue Patient MonitorMHX · Abbreviated	07/18/2012SE
K113441	Physiological Monitor, Patient MonitorMHX · Traditional	03/22/2012SE
K111905	Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…DXJ · Abbreviated	10/04/2011SE
K110474	Philips Intellivue TCG10LKD · Abbreviated	09/30/2011SE
K111083	Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50HGM · Abbreviated	08/17/2011SE
K110622	Intellivue Patient MonitorMHX · Special	03/31/2011SE

Questions and answers

When was Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 cleared by the FDA?

Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450 (K130849) received a 510(k) decision of Substantially Equivalent on June 14, 2013, 80 days after the submission was received.

What is the product code of K130849?

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.