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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 the device name listed in this FDA 510(k) record. The listed applicant is Daehan Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2019-04-03 under 510(k) 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. The listed applicant is Daehan Medical Systems Co., Ltd.. The 510(k) number is K180232.

When did DAEHAN Disposable CUP Electrodes receive FDA 510(k) clearance?

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

Who is the listed applicant for DAEHAN Disposable CUP Electrodes?

The FDA 510(k) record lists Daehan Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Daehan Medical Systems Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180247DAEHAN Adhesive Surface ElectrodesK161566DMS Disposable Subdermal Needle Electrodes

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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