Bwiii Eeg, Bwiii Eeg Plus, Bwiii Psg, Bwiii Psg Plus
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- BWIII EEG Plus EUDAMEDNeurovirtual FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- BWIII EEG EUDAMEDElectroencephalograph BWIII EEG Plus FDA UDI
- Model / Reference
- BWIII EEG EUDAMEDPV2007 EUDAMEDBWIII EEG Plus FDA UDI
- Description
- Electroencephalograph BWIII EEG Plus FDA UDI
Identifiers
- Catalog Number
- PV2007 FDA UDI
- Primary DI / UDI-DI
- 00850008393198 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850008393BWIIIEEGPT EUDAMED
- Direct Marketing DI
- 00850008393198 EUDAMED
- 510(k) Number
- FDA Product Code
- GWQ FDA 510(k)FDA UDI
- EMDN Code
- Z12100303 SYSTEMS FOR ANALYSING AND MANAGING EEG TRACES EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)FDA UDI
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The BWIII EEG, BWIII EEG Plus, BWIII PSG, and BWIII PSG Plus are Full-Montage Standard Electroencephalographs designed for clinical neurodiagnostic use. These systems enable high-density electroencephalography (EEG) and polysomnography (PSG) recordings, capturing brainwave activity and sleep parameters for diagnostic evaluation in neurology settings. The devices support comprehensive monitoring with configurable channel counts, including 36-channel and 50-channel configurations, to accommodate routine and advanced diagnostic protocols.
These systems are intended for use in clinical and research environments, providing real-time data acquisition, display, and archival capabilities for EEG and PSG studies. Supplied as reusable medical devices, they require proper calibration and maintenance per manufacturer guidelines. The BWIII series operates under FDA 510(k) clearance and EU MDR compliance, with regulatory classification as Class II devices. Storage and handling follow standard medical device protocols to ensure performance integrity and patient safety.
Frequently asked questions
What clinical environments and specialties are these devices primarily intended for use in?
The BWIII EEG, BWIII EEG Plus, BWIII PSG, and BWIII PSG Plus systems are designed for clinical neurodiagnostic use in neurology settings. They are specifically configured for capturing brainwave activity and sleep parameters, making them suitable for routine and advanced diagnostic evaluations in clinical and research environments focused on neurological assessments.
Are these devices single-use or reusable, and what maintenance is required?
These devices are reusable medical systems and require proper calibration and maintenance as outlined by the manufacturer’s guidelines. Since they are not disposable, regular upkeep ensures accurate data acquisition, real-time monitoring, and long-term reliability for EEG and PSG studies.
What channel configurations are available for these systems, and how do they accommodate different diagnostic needs?
The BWIII series supports configurable channel counts, including 36-channel and 50-channel configurations. These options allow flexibility to meet routine diagnostic protocols as well as more advanced monitoring requirements, ensuring adaptability for various clinical and research applications.
How should these devices be stored and handled to maintain performance and patient safety?
Storage and handling of the BWIII systems follow standard medical device protocols to preserve performance integrity and ensure patient safety. This includes adhering to manufacturer-recommended guidelines for environmental conditions, cleaning, and maintenance to prevent degradation or contamination.
What regulatory pathways have these devices undergone, and what classification do they hold?
The BWIII EEG, BWIII EEG Plus, BWIII PSG, and BWIII PSG Plus systems have undergone FDA 510(k) clearance and comply with EU MDR regulations. They are classified as Class II medical devices, reflecting their role in high-density electroencephalography and polysomnography for clinical and research use.
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: BWIII EEG - Neurovirtual, NEUROVIRTUAL, Bwiii Eeg, Bwiii Eeg Plus, Bwiii Psg, Bwiii Psg Plus, Neurovirtual BWIII EEG and PSG PLUS - POWER BASED MEDICAL
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K112107 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurovirtual Usa, Inc.
Sources (3)
- FDA 510(k) K112107 24 fields · synced Sep 18, 2026
- FDA UDI 2404dd9f-bd90-4aec-9511-045053cf073f 36 fields · synced May 30, 2026
- EUDAMED 11f4fc7b-c1ac-4f9e-9c62-12517e5fa37b 61 fields · synced Jul 15, 2026