# K063797: Geodesic Eeg System 300

- Pathway: 510(k) (Special)
- Applicant: Electrical Geodesics, Incorporated
- Decided: Jan 25, 2007 after 34 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: 3 generations back to K933233 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012079: Geodesic Eeg System, Model 200, Electrical Geodesics, Incorporated (2001) Summary page 1.

## Most influential descendants
- K131882: Geodesiceeg System 400 Series (Ges 400) (2014), 0 descendants of its own

## Indications for use
The Geodesic EEG System™ 300 (GES 300) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.

Source page: https://510kreport.com/device/K063797
Methodology: https://510kreport.com/methodology