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FDA 510(k)

ZMI Self-Adhesive Electrodes

K-Number: K180865 · 2018-06-28

ApplicantZmi Electronics , Ltd.
Decision Date2018-06-28
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ZMI Self-Adhesive Electrodes is a medical device manufactured by Zmi Electronics , Ltd.. It received FDA 510(k) clearance on 2018-06-28 under approval number K180865. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZMI Self-Adhesive Electrodes?

ZMI Self-Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2018-06-28. It is manufactured by Zmi Electronics , Ltd.. The 510(k) number is K180865.

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

ZMI Self-Adhesive Electrodes received FDA 510(k) clearance on 2018-06-28, under approval number K180865.

What company makes ZMI Self-Adhesive Electrodes?

ZMI Self-Adhesive Electrodes is manufactured by Zmi Electronics , Ltd..

What is the FDA product code for ZMI Self-Adhesive Electrodes?

The FDA product code for ZMI Self-Adhesive Electrodes is GXY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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