FDA 510(k)

Ennova 自己接着電極

K番号: K152648 · 2016-02-18

申請者Suzhou Ennova Electronics Technology Co.,Ltd

決定日2016-02-18

製品コードGXY

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

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.

よくある質問

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.

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Ennova 自己接着電極

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GXY）

公式ソース