Aingeal Activity System

Q: What is the product code of K153275?

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) K153275 · Intelesens, Ltd.

Substantially Equivalent

510(k) numberK153275

Submission

Device name: Aingeal Activity System
Applicant: Intelesens, Ltd.
Belfast, GB
Received: November 12, 2015
Decision date: February 26, 2016
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
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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
K151027	zensor systemMHX · Traditional	10/02/2015SE
K131000	V-Patch SystemDSI · Traditional	01/08/2014SE
K110015	Vitalsens, Aingeal, V-PodMHX · Traditional	05/20/2011SE

Questions and answers

When was Aingeal Activity System cleared by the FDA?

Aingeal Activity System (K153275) received a 510(k) decision of Substantially Equivalent on February 26, 2016, 106 days after the submission was received.

What is the product code of K153275?

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.