Self-adhesive Electrode
K-Number: K181234 · 2018-08-07
Decision Date2018-08-07
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Self-adhesive Electrode is a medical device manufactured by Dong Guan OU Kang Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-08-07 under approval 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. It is manufactured by Dong Guan OU Kang Electronics Co., Ltd.. The 510(k) number is K181234.
When was Self-adhesive Electrode approved by the FDA?
Self-adhesive Electrode received FDA 510(k) clearance on 2018-08-07, under approval number K181234.
What company makes Self-adhesive Electrode?
Self-adhesive Electrode is manufactured by Dong Guan OU Kang Electronics 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.