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FDA 510(k)

DAEHAN Adhesive Surface Electrodes

K-Number: K180247 · 2018-11-01

ApplicantDaehan Medical Systems Co., Ltd.
Decision Date2018-11-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DAEHAN Adhesive Surface Electrodes is a medical device manufactured by Daehan Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2018-11-01 under approval number K180247. 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 DAEHAN Adhesive Surface Electrodes?

DAEHAN Adhesive Surface Electrodes is a medical device that received FDA 510(k) clearance on 2018-11-01. It is manufactured by Daehan Medical Systems Co., Ltd.. The 510(k) number is K180247.

When was DAEHAN Adhesive Surface Electrodes approved by the FDA?

DAEHAN Adhesive Surface Electrodes received FDA 510(k) clearance on 2018-11-01, under approval number K180247.

What company makes DAEHAN Adhesive Surface Electrodes?

DAEHAN Adhesive Surface Electrodes is manufactured by Daehan Medical Systems Co., Ltd..

What is the FDA product code for DAEHAN Adhesive Surface Electrodes?

The FDA product code for DAEHAN Adhesive Surface 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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