# K963195: Wireless Eeg Recording System Model W32

- Pathway: 510(k) (Traditional)
- Applicant: Cme Telemetrix, Inc.
- Decided: Jul 29, 1997 after 348 days
- Product code: GYE (Encephalogram Telemetry System)
- Device class: 2
- Regulation: 21 CFR 882.1855
- 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 Wireless EEG Recording System Model W32 is intended to amplify, filter and convert into digital values electrophysiological voltages (primarily EEG, EOG, EMG, and ECG) sensed by conventional skin surface electrodes which have been attached to the patient. These signals are then transmitted via radio waves to the receiver portion of the system which transfers them to a computer for display and evaluation by appropriate health professionals.

Source page: https://510kreport.com/device/K963195
Methodology: https://510kreport.com/methodology