RX-1 Rhythm Express Remote Cardiac Monitoring System

Q: What is the product code of K200833?

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) K200833 · VivaQuant, Inc.

Substantially Equivalent

510(k) numberK200833

Submission

Device name: RX-1 Rhythm Express Remote Cardiac Monitoring System
Applicant: VivaQuant, Inc.
St. Paul, MN, US
Received: March 30, 2020
Decision date: September 2, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 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
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
K111487	NH-301 Ambulatory ECG Analysis SoftwareMLO · Special	Norav Medical Corp.	11/10/2011SE

More from Norav Medical Corp.

510(k)	Device	Decision
K241179	Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)QYX · Traditional	07/11/2025SE
K183704	RX-1 Rhythm Express Remote Cardiac Monitoring SystemDXH · Traditional	02/16/2019SE

Questions and answers

When was RX-1 Rhythm Express Remote Cardiac Monitoring System cleared by the FDA?

RX-1 Rhythm Express Remote Cardiac Monitoring System (K200833) received a 510(k) decision of Substantially Equivalent on September 2, 2020, 156 days after the submission was received.

What is the product code of K200833?

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