Cleared Traditional

EEG Electrode Template

K191225 · Rhythmlink International, LLC · Neurology
Aug 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K191225 is an FDA 510(k) clearance for the EEG Electrode Template, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on August 5, 2019, 90 days after receiving the submission on May 7, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K191225 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2019
Decision Date August 05, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

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