# K112353: Geodesic Eeg Mobile 100 (Gem 100)

- Pathway: 510(k) (Traditional)
- Applicant: Electrical Geodesics, Inc.
- Decided: Feb 17, 2012 after 185 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: 4 generations back to K933233 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033399: Geodesic Eeg System Series 100, Electrical Geodesics, Incorporated (2004) Summary page 1.

## Indications for use
The Geodesic EEG Mobile 100 (GEM 100) 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/K112353
Methodology: https://510kreport.com/methodology