FDA 510(k)

CASE V7.0 心臟檢測系統及 CardioSoft V7.0 心臟檢測系統

K 號：K231870 · 2023-12-13

申請人Ge Medical Systems Information Technologies, Inc.

決定日期2023-12-13

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K231870. 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 CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K231870.

When did CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System receive FDA 510(k) clearance?

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System received FDA 510(k) clearance on 2023-12-13, under 510(k) number K231870.

Who is the listed applicant for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

FDA 510(k) 記錄將 Ge Medical Systems Information Technologies, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

The FDA product code for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is DQK.

其他以 Ge Medical Systems Information Technologies, Inc. 為申請人之記錄

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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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