ZMI Self-Adhesive Electrodes

FDA 510(k) K180865 · Zmi Electronics , Ltd.

Substantially Equivalent

510(k) numberK180865

Submission

Device name
ZMI Self-Adhesive Electrodes
Applicant
Zmi Electronics , Ltd.
Kaohsiung, TW
Received
April 2, 2018
Decision date
June 28, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXY – Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Specialty
Neurology

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Questions and answers

When was ZMI Self-Adhesive Electrodes cleared by the FDA?

ZMI Self-Adhesive Electrodes (K180865) received a 510(k) decision of Substantially Equivalent on June 28, 2018, 87 days after the submission was received.

What is the product code of K180865?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.