Enguard Remote Patient Monitor
FDA 510(k) K020632 · Mennen Medical , Ltd.
510(k) numberK020632
Submission
- Device name
- Enguard Remote Patient Monitor
- Applicant
- Mennen Medical , Ltd.
Rehovot, IL - Received
- February 27, 2002
- Decision date
- March 15, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LQYX · Traditional | Lifewatch Services, Inc. | 08/01/2017SE |
| 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 |
More from Infobionic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141441 | Menntor X7DSI · Traditional | 01/09/2015SE |
| K131789 | Cerebralogik- AeegOMA · Traditional | 12/27/2013SE |
| K123792 | Horizon Xvu (FFR)DQX · Traditional | 08/30/2013SE |
| K093766 | Vitalogik 6000/6500DSI · Special | 05/07/2010SE |
| K091165 | Horizon XvuDQK · Traditional | 08/07/2009SE |
| K083063 | Bis Interface for Vitalogik Patient MonitorsOLW · Traditional | 12/16/2008SE |
| K081484 | Horizon XvuDQK · Special | 06/20/2008SE |
| K073140 | Vitalogik Model 4000/4500DSI · Special | 11/21/2007SE |
| K071899 | Bis Module for Envoy Patient MonitorOLW · Traditional | 10/22/2007SE |
| K071348 | Ems-Xl Cardiac Electrophysiology SystemDQK · Traditional | 09/07/2007SE |
Questions and answers
When was Enguard Remote Patient Monitor cleared by the FDA?
Enguard Remote Patient Monitor (K020632) received a 510(k) decision of Substantially Equivalent on March 15, 2002, 16 days after the submission was received.
What is the product code of K020632?
The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.