# K062533: Bwii Eeg Digital, Model PV 1652; Bwii PSG Digital, Model PV 1524

- Pathway: 510(k) (Traditional)
- Applicant: Neurovirtual USA, Inc.
- Decided: Dec 22, 2006 after 115 days
- Product code: OLT (Non-Normalizing Quantitative Electroencephalograph Software)
- 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 K932407 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K980214: Excel Neuro  Works, Excel Tech., Ltd. (1998) Summary page 2.
- K974718: Persyst Prism, Persyst Development Corp. (1998) Summary page 2.

## Most influential descendants
- K112107: Bwiii Eeg, Bwiii Eeg Plus, Bwiii PSG, Bwiii PSG Plus (2011), 0 descendants of its own

## Indications for use
The BWII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and dinical environments. It acquires, displays, and archives EEG and PSG data for on screen review, annotation and event marking by the user. The BWII system also allows for computer-assisted, user-controlled quantitative analysis of EEG. The BWII system is not intended to replace conventional devices or methods used for EEG and PSG monitoring in critical care or intraoperative settings. The BWII system requires competent user input, and its output must be reviewed and interpreted by a trained technicians or neurologists who will exercise professional judgment in using this information. The BWII system 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/K062533
Methodology: https://510kreport.com/methodology