Panels › Cardiovascular › Product code QYX · Class 2
Outpatient Cardiac Telemetry
Regulation 870.1025
1510(k)s in 12 months (21 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QYX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardionet, Inc. | 4 | 0 |
| Corventis, Inc. | 4 | 0 |
| Infobionic, Inc. | 2 | 0 |
| iRhythm Technologies, Inc. | 2 | 0 |
| RhythMedix, LLC | 2 | 0 |
| Applied Cardiac Systems, Inc. | 1 | 0 |
| Cardiac Telecom Corp. | 1 | 0 |
| Contex International Technologies (Canada), Inc. | 1 | 0 |
| Lifewatch Services, Inc. | 1 | 0 |
| Mennen Medical , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 2026 | K250793 | RhythmStar System (SL) RhythMedix, LLC | QYX |
| Jul 11, 2025 | K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) VivaQuant, Inc. | QYX |
| Oct 31, 2024 | K240653 | SmartCardia 7L Platform (MCT) Smartcardia SA, CH | QYX |
| Oct 21, 2024 | K240029 | Zio AT® device (A100A1001) iRhythm Technologies, Inc. | QYX |
| Jul 8, 2024 | K233584 | RhythmStar System RhythMedix, LLC | QYX |
| Sep 22, 2017 | K162956 | NOWCARDIO SYSTEM Contex International Technologies (Canada), Inc., CA | QYX |
| Aug 1, 2017 | K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L Lifewatch Services, Inc. | QYX |
| Jun 2, 2017 | K163512 | Zio AT ECG Monitoring System iRhythm Technologies, Inc. | QYX |
| Mar 11, 2016 | K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System Infobionic, Inc. | QYX |
| Sep 19, 2014 | K133753 | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR Infobionic, Inc. | QYX |
| Feb 6, 2014 | K133701 | NUVANT MCT SYSTEM Corventis, Inc. | QYX |
| Mar 7, 2012 | K113372 | NUVANT, MOBILC CARDIAC TELEMETRY Corventis, Inc. | QYX |
| Aug 24, 2011 | K111917 | NUVANT, MOBILE CARDIAC TELEMETRY Corventis, Inc. | QYX |
| Aug 24, 2011 | K103706 | THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR Applied Cardiac Systems, Inc. | QYX |
| Apr 8, 2010 | K093288 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION Cardionet, Inc. | QYX |
| Jun 19, 2009 | K090696 | NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM Corventis, Inc. | QYX |
| Dec 5, 2007 | K072558 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 Cardionet, Inc. | QYX |
| Nov 14, 2006 | K063222 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 Cardionet, Inc. | QYX |
| Oct 19, 2005 | K052240 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 Cardionet, Inc. | QYX |
| Mar 15, 2002 | K020632 | ENGUARD REMOTE PATIENT MONITOR Mennen Medical , Ltd., IL | QYX |
| Nov 13, 1998 | K982803 | HEARTLINK, MODEL II Cardiac Telecom Corp. | QYX |
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