FDA 510(k)

立體導航系統，VirtuEye V2，導航感測器NanoRest，導航單元Cube 4D

K 號：K211291 · 2021-07-19

決定日期2021-07-19

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

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2021-07-19 under 510(k) number K211291. 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 Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is a medical device that received FDA 510(k) clearance on 2021-07-19. The listed applicant is Fiagon GmbH. The 510(k) number is K211291.

When did Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D receive FDA 510(k) clearance?

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D received FDA 510(k) clearance on 2021-07-19, under 510(k) number K211291.

Who is the listed applicant for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

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 Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

The FDA product code for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is PGW.

其他以 Fiagon GmbH 為申請人之記錄

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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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