FDA Product Code
FDA Product Code QYX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250793 | RhythmStar System (SL) | RhythMedix, LLC | 2026-04-21 | Traditional | PDF ↗ |
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K240653 | SmartCardia 7L Platform (MCT) | Smartcardia SA | 2024-10-31 | Traditional | PDF ↗ |
| K240029 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024-10-21 | Traditional | PDF ↗ |
| K233584 | RhythmStar System | RhythMedix, LLC | 2024-07-08 | Traditional | PDF ↗ |
| K162956 | NOWCARDIO SYSTEM | Contex International Technologies (Canada), Inc. | 2017-09-22 | Abbreviated | PDF ↗ |
| K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L | Lifewatch Services, Inc. | 2017-08-01 | Traditional | PDF ↗ |
| K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017-06-02 | Traditional | PDF ↗ |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | 2016-03-11 | Abbreviated | PDF ↗ |
| K133753 | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | Infobionic, Inc. | 2014-09-19 | Traditional | PDF ↗ |
| K133701 | NUVANT MCT SYSTEM | Corventis, Inc. | 2014-02-06 | Special | PDF ↗ |
| K113372 | NUVANT, MOBILC CARDIAC TELEMETRY | Corventis, Inc. | 2012-03-07 | Special | PDF ↗ |
| K111917 | NUVANT, MOBILE CARDIAC TELEMETRY | Corventis, Inc. | 2011-08-24 | Abbreviated | PDF ↗ |
| K103706 | THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR | Applied Cardiac Systems, Inc. | 2011-08-24 | Abbreviated | PDF ↗ |
| K093288 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION | Cardionet, Inc. | 2010-04-08 | Abbreviated | PDF ↗ |
| K090696 | NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM | Corventis, Inc. | 2009-06-19 | Special | PDF ↗ |
| K072558 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 | Cardionet, Inc. | 2007-12-05 | Abbreviated | PDF ↗ |
| K063222 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 | Cardionet, Inc. | 2006-11-14 | Special | PDF ↗ |
| K052240 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 | Cardionet, Inc. | 2005-10-19 | Abbreviated | PDF ↗ |
| K020632 | ENGUARD REMOTE PATIENT MONITOR | Mennen Medical , Ltd. | 2002-03-15 | Special | PDF ↗ |
| K982803 | HEARTLINK, MODEL II | Cardiac Telecom Corp. | 1998-11-13 | Traditional | PDF ↗ |
Product code QYX · Class II · Cardiovascular. Data: openFDA.