LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L

Q: What is the product code of K170565?

The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.

FDA 510(k) K170565 · Lifewatch Services, Inc.

Substantially Equivalent

510(k) numberK170565

Submission

Device name: LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
Applicant: Lifewatch Services, Inc.
Rosemont, IL, US
Received: February 27, 2017
Decision date: August 1, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QYX – Outpatient Cardiac Telemetry
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1025
Specialty: Cardiovascular

Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of…

Other 510(k)s with product code QYX

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K250793	RhythmStar System (SL)QYX · Traditional	RhythMedix, LLC	04/21/2026SE
K241179	Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)QYX · Traditional	VivaQuant, Inc.	07/11/2025SE
K240653	SmartCardia 7L Platform (MCT)QYX · Traditional	Smartcardia SA	10/31/2024SE
K240029	Zio AT® device (A100A1001)QYX · Traditional	iRhythm Technologies, Inc.	10/21/2024SE
K233584	RhythmStar SystemQYX · Traditional	RhythMedix, LLC	07/08/2024SE
K162956	Nowcardio SystemQYX · Abbreviated	Contex International Technologies (Canada), Inc.	09/22/2017SE
K163512	Zio AT ECG Monitoring SystemQYX · Traditional	iRhythm Technologies, Inc.	06/02/2017SE
K160064	MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemQYX · Abbreviated	Infobionic, Inc.	03/11/2016SE
K133753	Mome ECG Continuous Detection and Arrhythmia DetectorQYX · Traditional	Infobionic, Inc.	09/19/2014SE
K133701	Nuvant MCT SystemQYX · Special	Corventis, Inc.	02/06/2014SE

Questions and answers

When was LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L cleared by the FDA?

LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (K170565) received a 510(k) decision of Substantially Equivalent on August 1, 2017, 155 days after the submission was received.

What is the product code of K170565?

The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.