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FDA 510(k)

Ennova Self-adhesive Electrode

K-Number: K152648 · 2016-02-18

ApplicantSuzhou Ennova Electronics Technology Co.,Ltd
Decision Date2016-02-18
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ennova Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Ennova Electronics Technology Co.,Ltd. It received FDA 510(k) clearance on 2016-02-18 under 510(k) 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. The listed applicant is Suzhou Ennova Electronics Technology Co.,Ltd. The 510(k) number is K152648.

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

Ennova Self-adhesive Electrode received FDA 510(k) clearance on 2016-02-18, under 510(k) number K152648.

Who is the listed applicant for Ennova Self-adhesive Electrode?

The FDA 510(k) record lists Suzhou Ennova Electronics Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Ennova 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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