# K163163: XLTEK EMU40EX EEG Headbox

- Pathway: 510(k) (Special)
- Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decided: Dec 14, 2016 after 34 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: 2 generations back to K980214 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053386: Xltek EMU40 Eeg Headbox, Model PK1072, Excel Tech., Ltd. (2006) Summary page 4.

## Indications for use
The XLTEK EMU40EX EEG Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software. The XLTEK EMU40EX EEG Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments. The XLTEK EMU40EX EEG Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

Source page: https://510kreport.com/device/K163163
Methodology: https://510kreport.com/methodology