# K131335: Bwmini Eeg, Bwminihst, Bwmini PSG

- Pathway: 510(k) (Traditional)
- Applicant: Neurovirtual USA, Inc.
- Decided: Feb 3, 2015 after 635 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 K946094 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042150: Xltek Trex Model#10309, Excel Tech., Ltd. (2004) Summary page 4.
- K946094: Cadwell Easy Ambulatory Eeg, Cadwell Laboratories, Inc. (1995) Summary page 4.

## Most influential descendants
- K191492: Maxxi Position Sensor (2020), 0 descendants of its own

## Indications for use
BWMini is an electroencephalograph, which is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head. BWMini is multi-channel (up to 32 channels) system designed for Electroencephalograph (EEG), Polysomnography (PSG) and Home Sleep Testing (HST) recording application, in research, home sleep studies, ambulatory and clinical environments. The BWMini does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Source page: https://510kreport.com/device/K131335
Methodology: https://510kreport.com/methodology