FDA 510(k)

ExacTrac動態 (2.0)；ExacTrac動態表面

K 號：K240431 · 2024-07-24

決定日期2024-07-24

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K240431. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Brainlab AG. The 510(k) number is K240431.

When did ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface receive FDA 510(k) clearance?

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface received FDA 510(k) clearance on 2024-07-24, under 510(k) number K240431.

Who is the listed applicant for ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

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 ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface?

The FDA product code for ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface is IYE.

其他以 Brainlab AG 為申請人之記錄

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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相關器械（代碼：IYE）

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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官方來源

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