Ennova Self-adhesive Electrode
K-Number: K152648 · 2016-02-18
Decision Date2016-02-18
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Ennova Self-adhesive Electrode is a medical device manufactured by Suzhou Ennova Electronics Technology Co.,Ltd. It received FDA 510(k) clearance on 2016-02-18 under approval number K152648. 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 Ennova Self-adhesive Electrode?
Ennova Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2016-02-18. It is manufactured by Suzhou Ennova Electronics Technology Co.,Ltd. The 510(k) number is K152648.
When was Ennova Self-adhesive Electrode approved by the FDA?
Ennova Self-adhesive Electrode received FDA 510(k) clearance on 2016-02-18, under approval number K152648.
What company makes Ennova Self-adhesive Electrode?
Ennova Self-adhesive Electrode is manufactured by Suzhou Ennova Electronics Technology Co.,Ltd.
What is the FDA product code for Ennova Self-adhesive Electrode?
The FDA product code for Ennova 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.