# K970703: Galileo Halley

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: May 19, 1997 after 82 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 K923950 (1993). 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)
- K923950: The Galileo Vega-24 Electroencephalograph, Biosound, Inc. (1993) Summary page 2.

## Indications for use
The intended use is for acquisition and storage of bioelectric signals produced by brain activity for the diagnosis and prognosis of neurological disease.

Source page: https://510kreport.com/device/K970703
Methodology: https://510kreport.com/methodology