Fukuda Denshi Dynascope Model DS-5800 Central Station Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K970585 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 Fukuda Denshi Dynascope Model DS-5800 Central Station Monitor is a detector and alarm device for arrhythmia, designed for use in hospital environments such as emergency rooms, intensive care units, and clinics. It functions as a central monitoring station that connects to Fukuda Denshi DS-5000 series bedside patient monitors to provide remote monitoring capabilities.
This device is intended for use in settings where patients are being monitored by bedside units and central station monitoring is desired, but it is not intended for home use. The device is classified as Class II under product code DSI with special controls, and it received FDA 510(k) clearance with number K970585 on September 9, 1997.
Frequently asked questions
What is the Fukuda Denshi Dynascope DS-5800 Central Station Monitor used for?
The Dynascope DS-5800 is a detector and alarm device specifically designed for arrhythmia monitoring. It functions as a central monitoring station that connects to Fukuda Denshi DS-5000 series bedside patient monitors, providing remote monitoring capabilities in hospital environments such as emergency rooms, intensive care units, and clinics.
Is the Dynascope DS-5800 suitable for home use?
No, the Dynascope DS-5800 is not intended for home use. It is designed specifically for hospital environments where patients are being monitored by bedside units and central station monitoring is desired. The device is classified as Class II under product code DSI with special controls.
What is the regulatory status of the Dynascope DS-5800?
The Dynascope DS-5800 received FDA 510(k) clearance with number K970585 on September 9, 1997. It is classified as Class II under product code DSI with special controls and was determined to be substantially equivalent to other legally marketed devices.
How does the Dynascope DS-5800 connect to bedside monitors?
The Dynascope DS-5800 functions as a central monitoring station that connects to Fukuda Denshi DS-5000 series bedside patient monitors. This connection enables remote monitoring capabilities, allowing healthcare providers to monitor multiple patients from a central location in hospital settings.
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: Fukuda Denshi Dynascope Model Ds-5800 Central Station Monitor, Customer and Technical Support | Fukuda Denshi, K970585 - Fukuda Denshi Dynascope Model Ds-5800 C..., Fukuda Denshi Dynascope Model Ds-5800 Central Station Monitor 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970585 | Class II | Active |
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Manufacturer
- Manufacturer
- Fukuda Denshi Usa, Inc.
Sources (1)
- FDA 510(k) K970585 24 fields · synced Sep 28, 2026