Cleared Traditional

ZMI Self-Adhesive Electrodes

K180865 · Zmi Electronics , Ltd. · Neurology
Jun 2018
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K180865 is an FDA 510(k) clearance for the ZMI Self-Adhesive Electrodes, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Zmi Electronics , Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on June 28, 2018, 87 days after receiving the submission on April 2, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K180865 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2018
Decision Date June 28, 2018
Days to Decision 87 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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