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FDA 510(k)

DAEHAN Disposable CUP Electrodes

K-Number: K180232 · 2019-04-03

ApplicantDaehan Medical Systems Co., Ltd.
Decision Date2019-04-03
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DAEHAN Disposable CUP Electrodes is a medical device manufactured by Daehan Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2019-04-03 under approval number K180232. 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 Disposable CUP Electrodes?

DAEHAN Disposable CUP Electrodes is a medical device that received FDA 510(k) clearance on 2019-04-03. It is manufactured by Daehan Medical Systems Co., Ltd.. The 510(k) number is K180232.

When was DAEHAN Disposable CUP Electrodes approved by the FDA?

DAEHAN Disposable CUP Electrodes received FDA 510(k) clearance on 2019-04-03, under approval number K180232.

What company makes DAEHAN Disposable CUP Electrodes?

DAEHAN Disposable CUP Electrodes is manufactured by Daehan Medical Systems Co., Ltd..

What is the FDA product code for DAEHAN Disposable CUP Electrodes?

The FDA product code for DAEHAN Disposable CUP Electrodes is GXY.

Other Devices by Daehan Medical Systems Co., Ltd.

K161566DMS Disposable Subdermal Needle Electrodes K180247DAEHAN Adhesive Surface Electrodes

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Official Source

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

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