FDA 510(k)

Brainlab Elements導航XT,導航3.0

K 號：K213930 · 2022-04-19

決定日期2022-04-19

產品代碼QQC

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

Brainlab Elements Guide XT, Guide 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2022-04-19 under 510(k) number K213930. The device is classified under product code QQC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Brainlab Elements Guide XT, Guide 3.0?

Brainlab Elements Guide XT, Guide 3.0 is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Brainlab AG. The 510(k) number is K213930.

When did Brainlab Elements Guide XT, Guide 3.0 receive FDA 510(k) clearance?

Brainlab Elements Guide XT, Guide 3.0 received FDA 510(k) clearance on 2022-04-19, under 510(k) number K213930.

Who is the listed applicant for Brainlab Elements Guide XT, Guide 3.0?

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

What is the FDA product code for Brainlab Elements Guide XT, Guide 3.0?

The FDA product code for Brainlab Elements Guide XT, Guide 3.0 is QQC.

其他以 Brainlab AG 為申請人之記錄

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相關器械（代碼：QQC）

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。

K243520牛薩伊確認Turing Medical Technologies, Inc.

官方來源

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