Identifiers
- 510(k) Number
- K001120 FDA 510(k)
- FDA Product Code
- DSI 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 Envoy Patient Monitor is a modular bedside patient monitoring system designed to detect and alarm for arrhythmias. Classified as a Detector and Alarm Device under the FDA’s nomenclature, it is intended for continuous monitoring of cardiac rhythms and related vital signs in clinical settings.
This device is supplied as a reusable system comprising a main processing unit, a color monitor, and a module rack for plug-in vital signs modules. It is intended for use in hospital environments, with connectivity to hospital information systems (HIS/LIS) and remote access capabilities via Ethernet LAN. The monitor is not described as single-use or sterile, and no MRI safety information is provided. Authorised under FDA 510(k) clearance (K001120), it falls under Class II regulatory classification.
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 - Envoy Community, Manuals and Specifications | MedWrench, ENVOY PATIENT MONITOR (K024245) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001120 | Class II | Active |
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Manufacturer
- Manufacturer
- Mennen Medical , Ltd.
Sources (1)
- FDA 510(k) K001120 24 fields · synced Oct 6, 2026