# K040360: EMU128S, Model EX-NW-128S

- Pathway: 510(k) (Special)
- Applicant: Excel Tech., Ltd.
- Decided: Mar 12, 2004 after 28 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
No predicates in its family tree.
31 later devices descend from it; 4 cite it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) XLTEK 128 Channel EEG Headbox: named in the summary without a submission number

## Most influential descendants
- K072964: Nicolet Cortical Stimulator (2008), 23 descendants of its own
- K110410: MS-120BK Electric Stimulator (Extension Unit) (2011), 13 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own

## Indications for use
The EMU128S is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals.

Source page: https://510kreport.com/device/K040360
Methodology: https://510kreport.com/methodology