Cleared Traditional

Disposable Non-invasive EEG Sensor

K220448 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Neurology
Jan 2023
Decision
337d
Days
Class 2
Risk

About This 510(k) Submission

K220448 is an FDA 510(k) clearance for the Disposable Non-invasive EEG Sensor, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 19, 2023, 337 days after receiving the submission on February 16, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K220448 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2022
Decision Date January 19, 2023
Days to Decision 337 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

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