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FDA 510(k)

Self-adhesive Electrode

K-Number: K222252 · 2023-01-19

ApplicantShenzhen Roundwhale Technology Co. , Ltd.
Decision Date2023-01-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Self-adhesive Electrode is a medical device manufactured by Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2023-01-19 under approval number K222252. 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 2023-01-19. It is manufactured by Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K222252.

When was Self-adhesive Electrode approved by the FDA?

Self-adhesive Electrode received FDA 510(k) clearance on 2023-01-19, under approval number K222252.

What company makes Self-adhesive Electrode?

Self-adhesive Electrode is manufactured by Shenzhen Roundwhale Technology Co. , Ltd..

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

The FDA product code for Self-adhesive Electrode 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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