Cleared Traditional

NEUROLOGICAL DIAGNOSTIC DEVICES

K943449 · Henley Intl. · Neurology
Nov 1995
Decision
485d
Days
Class 2
Risk

About This 510(k) Submission

K943449 is an FDA 510(k) clearance for the NEUROLOGICAL DIAGNOSTIC DEVICES, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on November 15, 1995, 485 days after receiving the submission on July 18, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K943449 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 1994
Decision Date November 15, 1995
Days to Decision 485 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

Similar Devices — GXY Electrode, Cutaneous

All 430
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
K260453 · Bionit Labs Srl · Mar 2026
Ceribell Instant EEG Headset
K254033 · Ceribell, Inc. · Feb 2026
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K251381 · Ceribell, Inc. · Oct 2025
Electrotherapy Electrodes
K250841 · Baisheng Medical Co., Ltd. · Aug 2025
IceCap product line
K243788 · Bioserenity Medical Devices Group · Mar 2025
Delphi MCS Electrode Cap
K243243 · Quantalx Neuroscience, Ltd. · Feb 2025