# K112817: Microeeg System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Signal Group Corporation
- Decided: Jun 19, 2012 after 265 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The microEEGO system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer. It is important to note that the microEEG® system collects and manages EEG data only. The system does not analyze or interpret EEG data in any manner. Rather, all such EEG analysis and interpretation is performed by a medical professional/clinician.

Source page: https://510kreport.com/device/K112817
Methodology: https://510kreport.com/methodology