Identifiers
- 510(k) Number
- K063055 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VS-800 Vital Signs Monitor is a medical device designed to monitor physiological parameters, including SpO2, pulse rate, non-invasive blood pressure (NIBP), and temperature. It is intended for use in clinical settings to provide real-time data on these vital signs, aiding in patient assessment and care.
The device is supplied as a single-use or reusable unit, depending on the specific configuration, and is intended for use in accordance with the manufacturer's instructions. It is not MRI safe, and storage should be maintained in a controlled environment as specified by the manufacturer. The device has received FDA 510(k) clearance, indicating it has been reviewed and determined to be substantially equivalent to a predicate device.
Frequently asked questions
What physiological parameters does the VS-800 monitor?
The VS-800 Vital Signs Monitor is designed to track and display real-time data for SpO2, pulse rate, non-invasive blood pressure (NIBP), and temperature.
Is the VS-800 monitor intended for single-use or reuse?
The device's intended use for reuse depends on its specific configuration, as it is supplied as either a single-use or reusable unit.
What is the storage requirement for the VS-800 monitor?
The device should be stored in a controlled environment as specified by the manufacturer to maintain its performance.
What regulatory status does the VS-800 monitor have?
The VS-800 Vital Signs Monitor has received FDA 510(k) clearance, indicating it has been reviewed and determined to be substantially equivalent to a predicate device.
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: Mindray VS-800 - Vital Signs Monitor - Soma Tech Intl, PDF Mindray VS-800 User Manual.pdf - iFixit, MINDRAY VS-800 SERVICE MANUAL Pdf Download | ManualsLib, Mindray VS 800 Vital Signs Monitor Operator's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063055 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (1)
- FDA 510(k) K063055 24 fields · synced Oct 6, 2026