FDA 510(k)

mi-eye 2、mi-eye 2モニター

K番号: K162475 · 2016-09-16

決定日2016-09-16

製品コードHRX

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

mi-eye 2, mi-eye 2 monitor is the device name listed in this FDA 510(k) record. The listed applicant is Trice Medical. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K162475. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the mi-eye 2, mi-eye 2 monitor?

mi-eye 2, mi-eye 2 monitor is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Trice Medical. The 510(k) number is K162475.

When did mi-eye 2, mi-eye 2 monitor receive FDA 510(k) clearance?

mi-eye 2, mi-eye 2 monitor received FDA 510(k) clearance on 2016-09-16, under 510(k) number K162475.

Who is the listed applicant for mi-eye 2, mi-eye 2 monitor?

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

What is the FDA product code for mi-eye 2, mi-eye 2 monitor?

The FDA product code for mi-eye 2, mi-eye 2 monitor is HRX.

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mi-eye 2、mi-eye 2モニター

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：HRX）

公式ソース