Enguard Remote Patient Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020632 FDA 510(k)
- FDA Product Code
- QYX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Enguard Remote Patient Monitor is classified as an Outpatient Cardiac Telemetry device, designed for remote monitoring of cardiac activity. It enables real-time or delayed transmission of patient physiological data, including ECG signals, from bedside monitors to a central location for observation and review. This facilitates continuous patient assessment in outpatient or ambulatory settings, supporting early detection of cardiac abnormalities. The device operates within the framework of cardiovascular telemetry systems, ensuring compatibility with existing hospital networks and monitoring infrastructure.
This device is supplied as a standalone system for remote monitoring, intended for use in clinical environments where continuous cardiac observation is required. It is not specified as single-use or reusable, but its design aligns with standard telemetry systems used in outpatient or ambulatory care settings. The device holds FDA 510(k) clearance under Special Review, with a classification as a Class II medical device (QYX product code). No sterility or MRI safety information is provided in the specifications. Storage and handling instructions are not detailed beyond standard medical device protocols.
Frequently asked questions
What is the Enguard Remote Patient Monitor used for?
The Enguard Remote Patient Monitor is designed for remote monitoring of cardiac activity in outpatient or ambulatory settings. It transmits real-time or delayed ECG signals from bedside monitors to a central location, enabling continuous assessment of patients’ heart rhythms. This supports early detection of cardiac abnormalities, which is critical for timely clinical intervention in non-hospitalized environments.
How is the Enguard Remote Patient Monitor supplied, and is it single-use or reusable?
The device is supplied as a standalone system for remote monitoring, intended for use in clinical environments requiring continuous cardiac observation. While the manufacturer does not explicitly state whether it is single-use or reusable, its design aligns with standard telemetry systems commonly used in outpatient or ambulatory care. This suggests it is likely intended for repeated use in controlled settings, following standard medical device maintenance protocols.
Does the Enguard Remote Patient Monitor require any special storage or handling?
The specifications do not provide detailed storage or handling instructions beyond general medical device protocols. As a Class II device, it should be stored in a clean, dry environment, protected from physical damage and extreme temperatures. Users should follow manufacturer guidelines for calibration, maintenance, and network compatibility to ensure reliable operation.
Is the Enguard Remote Patient Monitor compatible with existing hospital networks?
Yes, the device is designed to operate within cardiovascular telemetry systems and is intended to integrate with existing hospital networks and monitoring infrastructure. This compatibility ensures seamless data transmission from bedside monitors to central review stations, facilitating continuous patient monitoring in outpatient or ambulatory care settings.
What regulatory pathway does the Enguard Remote Patient Monitor follow?
The Enguard Remote Patient Monitor holds FDA 510(k) clearance under Special Review, classified as a Class II medical device with the product code QYX. This classification indicates it is substantially equivalent to a predicate device and has undergone review by the FDA’s Cardiovascular (CV) Advisory Committee. The device is not specified as sterile or MRI-safe, so users should verify compatibility with their facility’s specific protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Monitors | Mennen Medical, Mennen Medical EnGuard User Manual | Manualzz, ENGUARD REMOTE PATIENT MONITOR (K020632) — FDA 510 (k) | Innolitics, K020632 - ENGUARD REMOTE PATIENT MONITOR FDA 510 (k) APPLICATION FOR ..., Enguard Remote Patient Monitor 510 (k) FDA Premarket Notification ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020632 | Class II | Active |
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Manufacturer
- Manufacturer
- Mennen Medical , Ltd.
Sources (1)
- FDA 510(k) K020632 24 fields · synced Oct 1, 2026