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FDA 510(k)

Self-adhesive Electrode

K-Number: K181234 · 2018-08-07

ApplicantDong Guan OU Kang Electronics Co., Ltd.
Decision Date2018-08-07
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Dong Guan OU Kang Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-08-07 under 510(k) number K181234. 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 Self-adhesive Electrode?

Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2018-08-07. The listed applicant is Dong Guan OU Kang Electronics Co., Ltd.. The 510(k) number is K181234.

When did Self-adhesive Electrode receive FDA 510(k) clearance?

Self-adhesive Electrode received FDA 510(k) clearance on 2018-08-07, under 510(k) number K181234.

Who is the listed applicant for Self-adhesive Electrode?

The FDA 510(k) record lists Dong Guan OU Kang Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Self-adhesive Electrode?

The FDA product code for Self-adhesive Electrode is GXY.

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

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