FDA 510(k)

Hoggan Scientific® microFET2™

K番号: K162412 · 2017-03-09

決定日2017-03-09

製品コードLBB

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

Hoggan Scientific® microFET2™ is the device name listed in this FDA 510(k) record. The listed applicant is Hoggan Scientific, LLC. It received FDA 510(k) clearance on 2017-03-09 under 510(k) number K162412. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Hoggan Scientific® microFET2™?

Hoggan Scientific® microFET2™ is a medical device that received FDA 510(k) clearance on 2017-03-09. The listed applicant is Hoggan Scientific, LLC. The 510(k) number is K162412.

When did Hoggan Scientific® microFET2™ receive FDA 510(k) clearance?

Hoggan Scientific® microFET2™ received FDA 510(k) clearance on 2017-03-09, under 510(k) number K162412.

Who is the listed applicant for Hoggan Scientific® microFET2™?

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

What is the FDA product code for Hoggan Scientific® microFET2™?

The FDA product code for Hoggan Scientific® microFET2™ is LBB.

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医療機器の概要

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