# K110376: PE-210AK Switch Box

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corp.
- Decided: Jul 29, 2011 after 170 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 K040360 (2004). 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)
- K040360: EMU128S, Model EX-NW-128S, Excel Tech., Ltd. (2004) Summary page 1.

## Indications for use
EEG- 1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral activity for BEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis. The PE-21OAK Switch Box is an optional accessory for the EEG-1200A device. It is used with the BEG- 1200A to switch between EEG recording and conical stimulation using the same cortical electrode. The software is used for functional brain mapping to support diagnostic and surgical epilepsy procedures. The device is intended for use within a hospital or medical facility under direct supervision of a medical professional

Source page: https://510kreport.com/device/K110376
Methodology: https://510kreport.com/methodology