FDA 510(k)

三星不規則心律通知ECG監護器應用程序

K 號：K230292 · 2023-05-02

決定日期2023-05-02

產品代碼QDA

諮詢委員會履歷

決定相當於

器材摘要

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K230292. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K230292.

When did Samsung ECG Monitor Application with Irregular Heart Rhythm Notification receive FDA 510(k) clearance?

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification received FDA 510(k) clearance on 2023-05-02, under 510(k) number K230292.

Who is the listed applicant for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

FDA 510(k) 記錄將三星電子有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification?

The FDA product code for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is QDA.

其他以 Samsung Electronics Co., Ltd. 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：QDA）

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。

K240795Withings 心電圖應用程式Withings K243236WHOOP 心電圖功能（1.0）Whoop., Inc.K240909三星心電圖應用程式 v 1.3 (心電圖)Samsung Electronics Co., Ltd.K221774佳明心電圖應用程式Garmin International, Inc.K201525心電圖應用程式Apple, Inc.K200948Fitbit 心電圖應用程式Fitbit, Inc.

官方來源

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