FDA 510(k)

心電圖應用程式

K 號：K201525 · 2020-10-08

決定日期2020-10-08

產品代碼QDA

諮詢委員會履歷

決定相當於

器材摘要

ECG App is the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K201525. 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 ECG App?

ECG App is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Apple, Inc.. The 510(k) number is K201525.

When did ECG App receive FDA 510(k) clearance?

ECG App received FDA 510(k) clearance on 2020-10-08, under 510(k) number K201525.

Who is the listed applicant for ECG App?

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

What is the FDA product code for ECG App?

The FDA product code for ECG App is QDA.

其他以 Apple, 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。

K253582醫學影像校準功能（MICF）K250507高血壓通知功能（HTNF）K250143數位棱鏡校正功能 (DPCF)K242058數位棱鏡校正功能 (DPCF)K240929睡眠呼吸中止症通知功能（SANF）K231173不規則節律通知功能（IRNF）

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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.K230292三星不規則心律通知ECG監護器應用程序Samsung Electronics Co., Ltd.K221774佳明心電圖應用程式Garmin International, Inc.K200948Fitbit 心電圖應用程式Fitbit, Inc.

官方來源

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