# K081151: Compumedics Neuvo

- Pathway: 510(k) (Special)
- Applicant: Compumedics USA, Ltd.
- Decided: Sep 8, 2008 after 138 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 K001324 (2000). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023771: SYNAMPS2, Neuroscan (2003) Summary page 1.

## Most influential descendants
- K093223: Compumedics Grael System, Models: Grael, Grael Ecg (2010), 1 descendant of its own
- K230073: Okti (2023), 0 descendants of its own

## Indications for use
The Compumedics Neuvo System is intended for measuring recording of the electrical activity of a patient’s brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. The system is intended for the EEG and long/middle/short-latency EP registration in the research environment. The system is intended to be used by qualified/trained EEG technologists and/or physicians. The data acquired must be interpreted by a qualified physician.

Source page: https://510kreport.com/device/K081151
Methodology: https://510kreport.com/methodology