MD2000B Vital Sign Monitor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100740 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 MD2000B 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 to support clinical assessments in patient care settings.
This device is intended for single-use or reusable applications in clinical environments, including hospitals, outpatient clinics, and emergency care. Supplied sterile or non-sterile as specified, it operates in non-MRI environments and is available in a single model configuration (MD2000B). Authorised under FDA 510K and MDD, it adheres to regulatory standards for cardiovascular monitoring devices, with no third-party certification required.
Frequently asked questions
What clinical settings is the MD2000B Vital Sign Monitor intended for use in, and how does its single-use or reusable nature affect its application?
The MD2000B Vital Sign Monitor is designed for use in a variety of clinical environments, including hospitals, outpatient clinics, and emergency care settings. Its single-use or reusable nature allows flexibility depending on infection control protocols and facility policies. For single-use applications, it ensures patient safety by minimizing cross-contamination risks, while reusable models can be cost-effective for high-volume settings if properly sterilized and maintained between uses.
Is the MD2000B Vital Sign Monitor compatible with MRI environments, and what physiological parameters does it measure?
The MD2000B is explicitly designed for use in non-MRI environments, meaning it should not be used near MRI machines due to potential electromagnetic interference risks. It measures and displays key physiological parameters such as blood pressure, heart rate, and pulse rate, supporting continuous or intermittent monitoring for clinical assessments.
How is the MD2000B Vital Sign Monitor supplied, and what does this mean for its usability in sterile procedures?
The MD2000B is available in sterile or non-sterile configurations, depending on the specific supply order. This flexibility allows clinicians to choose the appropriate version based on the procedure’s sterility requirements—sterile models are ideal for invasive procedures or high-risk areas, while non-sterile models may suffice for routine or non-critical monitoring where contamination risks are lower.
What regulatory pathways does the MD2000B Vital Sign Monitor follow, and what does this imply for its compliance and third-party validation?
The MD2000B is authorized under FDA 510K (K100740) and the MDD (Medical Device Directive), with a classification as substantially equivalent to predicate devices in the cardiovascular category. It does not require third-party certification, meaning compliance is self-declared by the manufacturer under these regulatory frameworks. This pathway ensures adherence to safety and performance standards without additional external validation.
Are there multiple models of the MD2000B, or is it available in different sizes, and how might this impact user selection?
The MD2000B is supplied as a single model configuration, meaning there are no variations in size or additional sub-models. This simplifies inventory management and training, as all units share identical specifications and functionality. Clinicians or facilities should confirm the device’s compatibility with their workflows based on its core features—non-invasive monitoring of blood pressure, heart rate, and pulse rate—without needing to account for model-specific differences.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K100740 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Choice Electronic Technololgy Co., Ltd.
Sources (2)
- FDA 510(k) K100740 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026