Ensemble Central Station Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K970358 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 Ensemble Central Station Monitor is a device for central display of patient data, connected through an Ethernet LAN. It is designed to display data from up to 16 patients. The device is classified as a Detector And Alarm, Arrhythmia, under the product code DSI.
The Ensemble Central Station Monitor is supplied as a central station monitor, and is regulated under the FDA 510(k) clearance K970358. It is intended for use in a hospital setting, with remote access to the monitors from any location. The device is part of a wider network solution, with connection to HIS or LIS available.
Frequently asked questions
What is the Ensemble Central Station Monitor used for?
The Ensemble Central Station Monitor is used for central display of patient data, connected through an Ethernet LAN, and is intended for use in a hospital setting.
How many patients can the Ensemble Central Station Monitor display data from?
The Ensemble Central Station Monitor can display data from up to 16 patients.
Is the Ensemble Central Station Monitor regulated by the FDA?
Yes, the Ensemble Central Station Monitor is regulated under the FDA 510(k) clearance K970358.
What type of network solution is the Ensemble Central Station Monitor part of?
The Ensemble Central Station Monitor is part of a wider network solution, with connection to HIS or LIS available.
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 Ensemble Central Nurse Station User Manual, K970358 FDA 510(k) - ENSEMBLE CENTRAL STATION MONITOR, ENSEMBLE CENTRAL STATION MONITOR (K970358) — 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 | K970358 | Class II | Active |
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Manufacturer
- Manufacturer
- Mennen Medical, Inc.
Sources (1)
- FDA 510(k) K970358 24 fields · synced Sep 24, 2026