IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)

Q: What is the product code of K231671?

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) K231671 · Philips Medizin Systeme Boeblingen GmbH

Substantially Equivalent

510(k) numberK231671

Submission

Device name: IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
Applicant: Philips Medizin Systeme Boeblingen GmbH
Böblingen, DE
Received: June 8, 2023
Decision date: December 19, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 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
K252726	IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…MHX · Traditional	02/06/2026SE
K251146	IntelliVue Patient monitors MX400, MX450, MX500, MX550MHX · Traditional	10/17/2025SE
K233440	Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional	07/02/2024SE
K230604	IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)MHX · Traditional	11/22/2023SE
K223574	IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…MHX · Traditional	08/22/2023SE
K210906	IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…MHX · Traditional	10/07/2021SE
K212208	Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional	09/30/2021SE
K192137	IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550MHX · Abbreviated	09/11/2020SE
K182979	IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…MHX · Special	11/19/2019SE
K190624	EarlyVue VS30DSJ · Traditional	10/27/2019SE

Questions and answers

When was IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) cleared by the FDA?

IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) (K231671) received a 510(k) decision of Substantially Equivalent on December 19, 2023, 194 days after the submission was received.

What is the product code of K231671?

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.