# K014147: 80 Channel Eeg

- Pathway: 510(k) (Special)
- Applicant: Xltek
- Decided: Jan 14, 2002 after 27 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 K982479 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982479: Excel Ambulatory Eeg, Excel Tech., Ltd. (1998) Summary page 1.

## Indications for use
The 80 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.

Source page: https://510kreport.com/device/K014147
Methodology: https://510kreport.com/methodology