FDA 510(k)

Globe® 輸出場頻率系統

K 號：K250747 · 2025-06-25

決定日期2025-06-25

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

Globe® Pulsed Field System is the device name listed in this FDA 510(k) record. The listed applicant is Kardium, Inc.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K250747. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Globe® Pulsed Field System?

Globe® Pulsed Field System is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Kardium, Inc.. The 510(k) number is K250747.

When did Globe® Pulsed Field System receive FDA 510(k) clearance?

Globe® Pulsed Field System received FDA 510(k) clearance on 2025-06-25, under 510(k) number K250747.

Who is the listed applicant for Globe® Pulsed Field System?

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

What is the FDA product code for Globe® Pulsed Field System?

The FDA product code for Globe® Pulsed Field System is DQK.

其他以 Kardium, Inc. 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。

K250529Globe 引導器（601-01001）

相關器械（代碼：DQK）

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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