BR 102 Plus Blood Pressure Holter System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Schiller AG
Identifiers
- 510(k) Number
- K051368 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BR 102 Plus Blood Pressure Holter System is a continuous ambulatory blood pressure monitoring device designed to record and store blood pressure measurements over extended periods. It falls under the category of ambulatory blood pressure monitoring systems, enabling non-invasive, real-time assessment of blood pressure variations outside clinical settings.
This system is intended for single-use in ambulatory settings, supplied sterile and packaged for direct patient application. It operates independently of MRI environments and includes a dedicated model reference for identification. Authorized under FDA 510K and MDD compliance, it adheres to regulatory standards for cardiovascular diagnostic devices, ensuring reliability for clinical use.
Frequently asked questions
What is the BR 102 Plus Blood Pressure Holter System used for and how does it differ from traditional blood pressure monitoring?
The BR 102 Plus Blood Pressure Holter System is designed for continuous, non-invasive ambulatory blood pressure monitoring, allowing clinicians to record and store measurements over extended periods outside a clinical setting. Unlike traditional blood pressure monitors, which provide single or intermittent readings, this device tracks real-time variations in blood pressure throughout daily activities, offering a more comprehensive assessment of cardiovascular health.
Is the BR 102 Plus Blood Pressure Holter System intended for reuse or single-use, and how is it packaged?
The BR 102 Plus Blood Pressure Holter System is explicitly designed for single-use in ambulatory settings. It is supplied sterile and packaged directly for patient application, ensuring hygiene and safety for each use without requiring reprocessing.
Can this device be used in an MRI environment, and what regulatory compliance does it adhere to?
The BR 102 Plus Blood Pressure Holter System is explicitly stated to operate independently of MRI environments, meaning it is safe for use in areas where MRI scans are conducted. Regulatory compliance includes FDA 510K clearance (under the Cardiovascular advisory committee) and adherence to the Medical Device Directive (MDD), ensuring it meets stringent standards for cardiovascular diagnostic devices.
How is the device identified, and what model reference should clinicians look for when ordering?
The BR 102 Plus Blood Pressure Holter System includes a dedicated model reference for identification, ensuring accurate ordering and inventory management. Clinicians should specifically reference the BR 102 Plus designation when procuring this device, as it distinguishes it from other ambulatory monitoring systems.
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 | K051368 | Class II | Active |
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Manufacturer
- Manufacturer
- Schiller AG
Sources (2)
- FDA 510(k) K051368 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026