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FDA 510(k)

融合精簡導航系統

K 號:K153247 · 2016-02-18

決定日期2016-02-18
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

Fusion Compact Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K153247. 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 Fusion Compact Navigation System?

Fusion Compact Navigation System is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K153247.

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

Fusion Compact Navigation System received FDA 510(k) clearance on 2016-02-18, under 510(k) number K153247.

Who is the listed applicant for Fusion Compact Navigation System?

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

What is the FDA product code for Fusion Compact Navigation System?

The FDA product code for Fusion Compact Navigation System is PGW.

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其他以 Medtronic Navigation, Inc. 為申請人之記錄

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相關器械(代碼:PGW)

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