QYX · Outpatient Cardiac Telemetry
Cardiovascular · 21 CFR 870.1025 · Class 2
Overview
| Product Code | QYX |
|---|---|
| Device Name | Outpatient Cardiac Telemetry |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Classification Rationale
Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc. | Jul 11, 2025 | SESE |
| K240653 | SmartCardia 7L Platform (MCT) | Smartcardia SA | Oct 31, 2024 | SESE |
| K240029 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | Oct 21, 2024 | SESE |
| K233584 | RhythmStar System | RhythMedix, LLC | Jul 8, 2024 | SESE |
| K162956 | NOWCARDIO SYSTEM | Contex International Technologies (Canada), Inc. | Sep 22, 2017 | SESE |
| K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L | Lifewatch Services, Inc. | Aug 1, 2017 | SESE |
| K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | Jun 2, 2017 | SESE |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | Mar 11, 2016 | SESE |
| K133753 | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | Infobionic, Inc. | Sep 19, 2014 | SESE |
| K133701 | NUVANT MCT SYSTEM | Corventis, Inc. | Feb 6, 2014 | SESE |
| K113372 | NUVANT, MOBILC CARDIAC TELEMETRY | Corventis, Inc. | Mar 7, 2012 | SESE |
| K111917 | NUVANT, MOBILE CARDIAC TELEMETRY | Corventis, Inc. | Aug 24, 2011 | SESE |
| K103706 | THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR | Applied Cardiac Systems, Inc. | Aug 24, 2011 | SESE |
| K093288 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION | Cardionet, Inc. | Apr 8, 2010 | SESE |
| K090696 | NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM | Corventis, Inc. | Jun 19, 2009 | SESE |
| K072558 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 | Cardionet, Inc. | Dec 5, 2007 | SESE |
| K063222 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 | Cardionet, Inc. | Nov 14, 2006 | SESE |
| K052240 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 | Cardionet, Inc. | Oct 19, 2005 | SESE |
| K020632 | ENGUARD REMOTE PATIENT MONITOR | Mennen Medical , Ltd. | Mar 15, 2002 | SESE |
| K982803 | HEARTLINK, MODEL II | Cardiac Telecom Corp. | Nov 13, 1998 | SESE |
Top Applicants
- Cardionet, Inc. — 4 clearances
- Corventis, Inc. — 4 clearances
- Infobionic, Inc. — 2 clearances
- iRhythm Technologies, Inc. — 2 clearances
- Applied Cardiac Systems, Inc. — 1 clearance
