# K963662: Galileo Evoked Potentialre

- Pathway: 510(k) (Traditional)
- Applicant: Biosound, Inc.
- Decided: Feb 26, 1997 after 166 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- 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 K890495 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922488: Phasis Electromyograph, Biosound, Inc. (1993) Summary page 2.
- K890495: Nicolet Viking II System, Nicolet Instrument Corp. (1989) Summary page 2.

## Indications for use
The Galileo Electroencephalograph with Evoked Potential option is indicated for use in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system.

Source page: https://510kreport.com/device/K963662
Methodology: https://510kreport.com/methodology