Matrix Holter System, Model M12

Q: What is the product code of K051730?

The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.

FDA 510(k) K051730 · Global Instrumentation, LLC

Substantially Equivalent

510(k) numberK051730

Submission

Device name: Matrix Holter System, Model M12
Applicant: Global Instrumentation, LLC
Manlius, NY, US
Received: June 27, 2005
Decision date: September 26, 2005
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2800
Specialty: Cardiovascular

Other 510(k)s with product code MLO

510(k)	Device	Applicant	Decision
K261580	ZBPro Diagnostic (Version 2.0)MLO · Traditional	Zbeats, Inc.	09/11/2026SE
K241890	Philips Holter Analysis SystemMLO · Traditional	Philips Medizin Systeme Böblingen GmbH	03/21/2025SE
K240794	Frontier X PlusMLO · Traditional	Fourth Frontier Technologies Pvt, Ltd.	11/08/2024SE
K200833	RX-1 Rhythm Express Remote Cardiac Monitoring SystemMLO · Traditional	VivaQuant, Inc.	09/02/2020SE
K193177	Cer-SMLO · Traditional	Cardiocalm	08/26/2020SE
K182030	Faros MobileMLO · Abbreviated	Bittium Biosignals , Ltd.	11/08/2018SE
K140847	Cardiospy ECG Holter SystemsMLO · Traditional	Labtech Kft.	12/05/2014SE
K131897	CV3000 Holter Analysis SystemMLO · Traditional	Vales & Hills Biomedical Tech. , Ltd.	11/26/2013SE
K130660	Audicor Cpam with SDB (Single Sensor)MLO · Traditional	Inovise Medical, Inc.	10/11/2013SE
K120462	Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…MLO · Traditional	Inovise Medical, Inc.	09/20/2012SE

More from Inovise Medical, Inc.

510(k)	Device	Decision
K252840	M12 Telemetry SystemMHX · Traditional	05/29/2026SE
K202456	M5 RecorderDSH · Abbreviated	12/29/2020SE
K162463	Matrix Data Management SystemDXN · Traditional	05/24/2017SE
K152701	Matrix Mini ECG MonitorDSI · Abbreviated	04/22/2016SE

Questions and answers

When was Matrix Holter System, Model M12 cleared by the FDA?

Matrix Holter System, Model M12 (K051730) received a 510(k) decision of Substantially Equivalent on September 26, 2005, 91 days after the submission was received.

What is the product code of K051730?

The FDA product code is MLO – Electrocardiograph, Ambulatory, With Analysis Algorithm, a Class II (moderate risk) device regulated under 21 CFR 870.2800.