# K021599: 96 Channel Eeg Headbox Model EMU96

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Aug 13, 2002 after 90 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: 4 generations back to K962603 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000919: 128 Channel Eeg Headbox, Model EX-NW-128, Excel Tech., Ltd. (2000) Summary page 1.
- K992340: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-PE, Masimo Corp. (1999) Summary page 1.

## Indications for use
The 96 Channel EEG Headbox is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals with additional capabilities to record other physiological signals such as pulse oximetry.

Source page: https://510kreport.com/device/K021599
Methodology: https://510kreport.com/methodology