Skip to content

Wireless EEG Recording System Model W32

by Cme Telemetrix, Inc.

510(k) K963195

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963195 Date29 Jul 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GYE
Device Class
Class II
Regulation
21 CFR Part 882.1855
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Wireless EEG Recording System Model W32 is an encephalogram telemetry system designed to amplify, filter, and convert electrophysiological voltages into digital values. It processes signals sensed by conventional skin surface electrodes attached to the patient, including EEG, EOG, EMG, and ECG data.

This device is classified as a Class 2 medical device under regulation number 882.1855. It has received FDA 510(k) clearance, identified by k-number K963195.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of physiological signals can the Model W32 process?

    The system is designed to process signals sensed by conventional skin surface electrodes, including EEG, EOG, EMG, and ECG data. It functions by amplifying, filtering, and converting these electrophysiological voltages into digital values.

  • What is the regulatory status of the Wireless EEG Recording System Model W32?

    This device is classified as a Class 2 medical device under regulation number 882.1855. It has received FDA 510(k) clearance, which is identified by k-number K963195.

  • How does the system function during patient monitoring?

    The system operates as an encephalogram telemetry system. It captures signals from electrodes attached to the patient's skin and converts those analog voltages into a digital format for recording and analysis.