# K012079: Geodesic Eeg System, Model 200

- Pathway: 510(k) (Traditional)
- Applicant: Electrical Geodesics, Incorporated
- Decided: Sep 19, 2001 after 78 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 K933233 (1994). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973883: Bio-Logic Ceegraph 128-Channel Recording System, Bio-Logic Systems Corp. (1998) Summary page 1.
- K780045: Electrode Cap, Electro-Cap Intl., Inc. (1978) Summary page 1.

## Most influential descendants
- K063797: Geodesic Eeg System 300 (2007), 1 descendant of its own
- K033399: Geodesic Eeg System Series 100 (2004), 1 descendant of its own
- K131882: Geodesiceeg System 400 Series (Ges 400) (2014), 0 descendants of its own
- K112353: Geodesic Eeg Mobile 100 (Gem 100) (2012), 0 descendants of its own

## Indications for use
The Geodesic EEG System 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/K012079
Methodology: https://510kreport.com/methodology