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MD2000A Vital Sign Monitor

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K083466

by Beijing Choice Electronic Technololgy Co., Ltd.

Identifiers

510(k) Number
K083466 FDA 510(k)
FDA Product Code
DQA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MD2000A Vital Sign Monitor is a medical device classified as a non-invasive blood pressure monitor and vital sign monitor, designed to measure and display key physiological parameters such as blood pressure, heart rate, and pulse rate. It provides continuous or intermittent monitoring of these vital signs, supporting clinical assessments in patient care settings.

This device is intended for single-use or reusable application in clinical environments, including hospitals, outpatient clinics, and emergency care. Supplied sterile or non-sterile based on configuration, it adheres to FDA 510(k) clearance (K083466) and MDD compliance, ensuring regulatory alignment for cardiovascular monitoring. The monitor operates independently of MRI environments and is available in a single model configuration (MD2000A) with no specified size variations.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Beijing Choice Electronic Technololgy Co., Ltd.

Sources (2)

  • FDA 510(k) K083466 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026