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FDA 510(k)

Hoggan Scientific® 微FET2™

K 號:K162412 · 2017-03-09

決定日期2017-03-09
產品代碼LBB
諮詢委員會或
決定相當於

器材摘要

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.

常見問題

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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