FDA 510(k)

DL自己接着電極

K番号: K182111 · 2019-01-17

決定日2019-01-17

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

DL Self-adhesive Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing DL Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2019-01-17 under 510(k) number K182111. 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 DL Self-adhesive Electrode?

DL Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2019-01-17. The listed applicant is Shaoxing DL Healthcare Co., Ltd.. The 510(k) number is K182111.

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

DL Self-adhesive Electrode received FDA 510(k) clearance on 2019-01-17, under 510(k) number K182111.

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

The FDA 510(k) record lists Shaoxing DL Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for DL Self-adhesive Electrode is GXY.

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DL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