# K964280: DG Nervus

- Pathway: 510(k) (Traditional)
- Applicant: Medelec, Ltd.
- Decided: Jan 27, 1997 after 91 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K061908: Nicoletone System V32 Amplifier (2006), 19 descendants of its own
- 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

## Recalls of this device
- Sep 11, 2015 · Class II · 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.

Source page: https://510kreport.com/device/K964280
Methodology: https://510kreport.com/methodology