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FDA 510(k)

飛安導航系統

K 號:K162176 · 2016-12-01

申請人Fiagon GmbH
決定日期2016-12-01
產品代碼PGW
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

Fiagon Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K162176. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fiagon Navigation System?

Fiagon Navigation System is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Fiagon GmbH. The 510(k) number is K162176.

When did Fiagon Navigation System receive FDA 510(k) clearance?

Fiagon Navigation System received FDA 510(k) clearance on 2016-12-01, under 510(k) number K162176.

Who is the listed applicant for Fiagon Navigation System?

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

What is the FDA product code for Fiagon Navigation System?

The FDA product code for Fiagon Navigation System is PGW.

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其他以 Fiagon GmbH 為申請人之記錄

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相關器械(代碼:PGW)

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