FDA 510(k)

RIWOtrack導航系統

K 號：K230700 · 2023-11-20

決定日期2023-11-20

產品代碼OLO

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

RIWOtrack 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 2023-11-20 under 510(k) number K230700. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RIWOtrack Navigation System?

RIWOtrack Navigation System is a medical device that received FDA 510(k) clearance on 2023-11-20. The listed applicant is Fiagon GmbH. The 510(k) number is K230700.

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

RIWOtrack Navigation System received FDA 510(k) clearance on 2023-11-20, under 510(k) number K230700.

Who is the listed applicant for RIWOtrack 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 RIWOtrack Navigation System?

The FDA product code for RIWOtrack Navigation System is OLO.

其他以 Fiagon GmbH 為申請人之記錄

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相關器械（代碼：OLO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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