FDA 510(k)

Fitbit 不規則節律通知

K 號：K212372 · 2022-04-08

決定日期2022-04-08

產品代碼QDB

諮詢委員會履歷

決定相當於

器材摘要

Fitbit Irregular Rhythm Notifications is the device name listed in this FDA 510(k) record. The listed applicant is Fitbit, Inc.. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K212372. The device is classified under product code QDB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fitbit Irregular Rhythm Notifications?

Fitbit Irregular Rhythm Notifications is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Fitbit, Inc.. The 510(k) number is K212372.

When did Fitbit Irregular Rhythm Notifications receive FDA 510(k) clearance?

Fitbit Irregular Rhythm Notifications received FDA 510(k) clearance on 2022-04-08, under 510(k) number K212372.

Who is the listed applicant for Fitbit Irregular Rhythm Notifications?

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 Irregular Rhythm Notifications?

The FDA product code for Fitbit Irregular Rhythm Notifications is QDB.

其他以 Fitbit, 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。

K200948Fitbit 心電圖應用程式

相關器械（代碼：QDB）

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。

K231173不規則節律通知功能（IRNF）Apple, Inc.K213971心房顫動歷史功能Apple, Inc.K212516IRNF應用程式Apple, Inc.

官方來源

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