# K180524: EEG-Now

- Pathway: 510(k) (Traditional)
- Applicant: Encephalodynamics, Inc.
- Decided: May 18, 2018 after 80 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- 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
An electroencephalogram (EEG) electrode array intended for use in the ER, ICU, and OR for recording of STAT EEGs in patients of 18 years of age and older.

Source page: https://510kreport.com/device/K180524
Methodology: https://510kreport.com/methodology