# K112107: Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus

- Pathway: 510(k) (Traditional)
- Applicant: Neurovirtual USA, Inc.
- Decided: Oct 28, 2011 after 98 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 K932407 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932407: Cadwell Easy Writer and Easy Reader, Cadwell Laboratories, Inc. (1994) Summary page 1.
- K991900: Xltek Polysomnography Headbox, Model # PSG-40, Excel Tech., Ltd. (1999) Summary page 1.
- K062533: Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524, Neurovirtual USA, Inc. (2006) Summary page 1.

## Indications for use
The BWIII system may be used for electroencephalography (EEG) and sleep recordings (Polysomnography) in research and Clinical environments. It acquires displays and archives EEG and PSG data for on-screen review, annotation, and event-marking by the user. The BWIII requires competent user input, and its output must be reviewed and interpreted by a trained physician who will exercise professional judgment in using this information. The BWIII 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/K112107
Methodology: https://510kreport.com/methodology