DG NERVUS
510(k) K964280
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964280 | Date27 Jan 1997 | StatusActive |
Recalls
-
- Terminated Z-0117-2016
When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GWQ
- FDA applicant
- Medelec , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The DG NERVUS is a Full-Montage Standard Electroencephalograph (EEG) device, designed for recording electrical activity in the brain. It captures and displays brain wave patterns to aid in the diagnosis and monitoring of neurological conditions, including epilepsy, sleep disorders, and other brain-related abnormalities. The device employs multiple electrodes placed on the scalp to measure voltage fluctuations, providing clinicians with critical insights into brain function.
This device is intended for use in clinical settings, such as hospitals, neurology clinics, and sleep laboratories, where EEG monitoring is conducted. Supplied as a reusable medical instrument, the DG NERVUS adheres to FDA regulatory standards under the Traditional 510(k) pathway, with clearance granted in 1997 under product code GWQ. It is classified as a Class 2 device under the FDA’s regulation number 882.1400, with no third-party involvement in its review. The device’s specifications and compliance are documented in the FDA’s OpenFDA database.
Other devices from Medelec, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the DG NERVUS used for?
The DG NERVUS is a full-montage electroencephalograph (EEG) designed to capture and display electrical activity in the brain. Clinicians use it to diagnose and monitor neurological conditions such as epilepsy, sleep disorders, and other brain-related abnormalities by analyzing voltage fluctuations recorded through multiple scalp electrodes.
Is the DG NERVUS a single-use or reusable device?
The DG NERVUS is supplied as a reusable medical instrument. It is intended for repeated use in clinical environments like hospitals, neurology clinics, and sleep laboratories, adhering to FDA regulatory standards for reusable medical devices.
What regulatory pathway does the DG NERVUS follow?
The DG NERVUS was cleared under the Traditional 510(k) pathway by the FDA in 1997, classified as a Class 2 device under regulation number 882.1400. It was reviewed by the Neurology (NE) Advisory Committee and received clearance under product code GWQ, with no third-party involvement in the review process.
Where can the DG NERVUS be used?
This device is intended for use in clinical settings such as hospitals, neurology clinics, and sleep laboratories where EEG monitoring is conducted. Its design supports comprehensive brain activity analysis for diagnostic and monitoring purposes.
How does the DG NERVUS differ from other EEG devices?
The DG NERVUS is specifically a full-montage EEG device, meaning it uses a comprehensive electrode placement system to capture detailed brain wave patterns. Unlike some simplified or limited-montage EEG devices, it provides extensive coverage for accurate diagnosis of complex neurological conditions.