FDA 510(k)

ATL Anchors

K番号: K200503 · 2020-09-02

決定日2020-09-02

製品コードMBI

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

ATL Anchors is the device name listed in this FDA 510(k) record. The listed applicant is International Life Sciences. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K200503. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the ATL Anchors?

ATL Anchors is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is International Life Sciences. The 510(k) number is K200503.

When did ATL Anchors receive FDA 510(k) clearance?

ATL Anchors received FDA 510(k) clearance on 2020-09-02, under 510(k) number K200503.

Who is the listed applicant for ATL Anchors?

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

What is the FDA product code for ATL Anchors?

The FDA product code for ATL Anchors is MBI.

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