FDA 510(k)

Withings 心電圖應用程式

K 號：K240795 · 2025-06-15

決定日期2025-06-15

產品代碼QDA

諮詢委員會履歷

決定相當於

器材摘要

Withings ECG App is the device name listed in this FDA 510(k) record. The listed applicant is Withings. It received FDA 510(k) clearance on 2025-06-15 under 510(k) number K240795. 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 Withings ECG App?

Withings ECG App is a medical device that received FDA 510(k) clearance on 2025-06-15. The listed applicant is Withings. The 510(k) number is K240795.

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

Withings ECG App received FDA 510(k) clearance on 2025-06-15, under 510(k) number K240795.

Who is the listed applicant for Withings ECG App?

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

What is the FDA product code for Withings ECG App?

The FDA product code for Withings ECG App is QDA.

其他以 Withings 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。

K252474Withings BeamO (SCT02)K231667Withings 睡眠藥物 K230812Withings Scan Monitor 2.0 K160544Withings Thermo（型號SCT01）

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。

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.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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