FDA 510(k)

Fitbit 心電圖應用程式

K 號：K200948 · 2020-09-11

決定日期2020-09-11

產品代碼QDA

諮詢委員會履歷

決定相當於

器材摘要

Fitbit ECG App is the device name listed in this FDA 510(k) record. The listed applicant is Fitbit, Inc.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K200948. 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 Fitbit ECG App?

Fitbit ECG App is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Fitbit, Inc.. The 510(k) number is K200948.

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

Fitbit ECG App received FDA 510(k) clearance on 2020-09-11, under 510(k) number K200948.

Who is the listed applicant for Fitbit ECG App?

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

What is the FDA product code for Fitbit ECG App?

The FDA product code for Fitbit ECG App is QDA.

其他以 Fitbit, Inc. 為申請人之記錄

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K212372Fitbit 不規則節律通知

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.K201525心電圖應用程式Apple, Inc.

官方來源

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