FDA 510(k)

アイブズ MR条件付きカップ電極

K番号: K171102 · 2017-12-21

決定日2017-12-21

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

Ives MR Conditional Cup Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Ives Egg Solutions. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K171102. 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 Ives MR Conditional Cup Electrode?

Ives MR Conditional Cup Electrode is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Ives Egg Solutions. The 510(k) number is K171102.

When did Ives MR Conditional Cup Electrode receive FDA 510(k) clearance?

Ives MR Conditional Cup Electrode received FDA 510(k) clearance on 2017-12-21, under 510(k) number K171102.

Who is the listed applicant for Ives MR Conditional Cup Electrode?

The FDA 510(k) record lists Ives Egg Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ives MR Conditional Cup Electrode?

The FDA product code for Ives MR Conditional Cup Electrode is GXY.

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アイブズ MR条件付きカップ電極

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