# K061908: Nicoletone System V32 Amplifier

- Pathway: 510(k) (Abbreviated)
- Applicant: Viasys Neuro Care
- Decided: Nov 6, 2006 after 124 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964280 (1997). 2 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964280: DG Nervus, Medelec, Ltd. (1997) Summary page 1.
- K990522: Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital Eeg and Sleep Acquis, Lamont Medical, Inc. (1999) Summary page 1.

## Most influential descendants
- K143233: Mitsar-EEG (2015), 11 descendants of its own
- K103140: Nicolet Wireless Eeg (2011), 7 descendants of its own
- K171781: eVox System (2017), 6 descendants of its own
- K192753: NeuralScan System (2020), 3 descendants of its own
- K221963: Cumulus Functional Neurophysiology Platform (2023), 1 descendant of its own

## Indications for use
NicoletOne System V32 Amplifier is a stand alone electroencephalography (EEG) amplifier for the recording of electrical signals from the brain. An optional feature of pulse oximetery (SPO2) is available.

Source page: https://510kreport.com/device/K061908
Methodology: https://510kreport.com/methodology