FDA 510(k)

EUROSCREW NG；EUROSCREW TCP NG

K番号: K230394 · 2023-05-12

決定日2023-05-12

製品コードMAI

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

EUROSCREW NG; EUROSCREW TCP NG is the device name listed in this FDA 510(k) record. The listed applicant is Teknimed. It received FDA 510(k) clearance on 2023-05-12 under 510(k) number K230394. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the EUROSCREW NG; EUROSCREW TCP NG?

EUROSCREW NG; EUROSCREW TCP NG is a medical device that received FDA 510(k) clearance on 2023-05-12. The listed applicant is Teknimed. The 510(k) number is K230394.

When did EUROSCREW NG; EUROSCREW TCP NG receive FDA 510(k) clearance?

EUROSCREW NG; EUROSCREW TCP NG received FDA 510(k) clearance on 2023-05-12, under 510(k) number K230394.

Who is the listed applicant for EUROSCREW NG; EUROSCREW TCP NG?

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

What is the FDA product code for EUROSCREW NG; EUROSCREW TCP NG?

The FDA product code for EUROSCREW NG; EUROSCREW TCP NG is MAI.

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EUROSCREW NG；EUROSCREW TCP NG

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：MAI）

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