Nicoletone System V32 Amplifier
510(k) K061908
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061908 | Date6 Nov 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GWQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Nicoletone System V32 Amplifier is a Full-Montage Standard Electroencephalograph amplifier designed for neurological monitoring. It records electrical activity from the brain via scalp electrodes, enabling clinicians to diagnose and evaluate conditions such as epilepsy, sleep disorders, and other neurological abnormalities. The device amplifies and digitizes EEG signals for real-time analysis and long-term monitoring.
This system is intended for use in clinical settings, including hospitals and neurology clinics, where continuous or intermittent EEG recordings are required. Supplied as a reusable medical device, it is not single-use and must be maintained according to manufacturer guidelines. The amplifier operates within standard MRI safety parameters for non-MRI environments and is available in a single configuration (V32). Authorized under FDA 510(k) clearance (K061908), it adheres to regulatory standards for Class II devices under 21 CFR 882.1400.
Other devices from Viasys Neuro Care
Questions
AI-generated answers, 19 Sep 2026
What clinical conditions is the Nicoletone System V32 Amplifier primarily used to diagnose or monitor?
The Nicoletone System V32 Amplifier is designed for neurological monitoring to diagnose and evaluate conditions such as epilepsy, sleep disorders, and other neurological abnormalities. It records electrical brain activity via scalp electrodes, enabling real-time analysis and long-term EEG monitoring in clinical settings like hospitals and neurology clinics.
Is the Nicoletone System V32 Amplifier a single-use or reusable device, and what maintenance is required?
The Nicoletone System V32 Amplifier is a reusable medical device, not intended for single-use. It must be maintained according to the manufacturer’s guidelines to ensure proper functionality and safety over repeated use.
What is the regulatory pathway for the Nicoletone System V32 Amplifier, and what class does it fall under?
The Nicoletone System V32 Amplifier is authorized under FDA 510(k) clearance (K061908) and is classified as a Class II device under 21 CFR 882.1400. It was determined to be substantially equivalent to a predicate device through an abbreviated 510(k) process.
Are there multiple configurations or models available for the Nicoletone System V32 Amplifier, or is it available in a single version?
The Nicoletone System V32 Amplifier is available in a single configuration, labeled as the V32 model. This version is designed as a full-montage standard electroencephalograph amplifier for neurological monitoring.
What safety considerations should be taken into account when using the Nicoletone System V32 Amplifier in a clinical environment?
The Nicoletone System V32 Amplifier operates within standard MRI safety parameters for non-MRI environments, meaning it is not intended for use inside an MRI scanner. Clinicians should ensure proper setup, calibration, and adherence to manufacturer guidelines to maintain accuracy and safety during EEG recordings.