Cleared Abbreviated

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

K200162 · Wuhan Greentek Pty , Ltd. · Neurology

Apr 2020

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K200162 is an FDA 510(k) clearance for the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP), a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Wuhan Greentek Pty , Ltd. (Wuhan, CN). The FDA issued a Cleared decision on April 21, 2020, 90 days after receiving the submission on January 22, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K200162 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2020
Decision Date	April 21, 2020
Days to Decision	90 days
Submission Type	Abbreviated
Review Panel	Neurology (NE)
Summary	Summary PDF