FDA 510(k)

IRNF應用程式

K 號：K212516 · 2021-10-22

決定日期2021-10-22

產品代碼QDB

諮詢委員會履歷

決定相當於

器材摘要

IRNF 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 2021-10-22 under 510(k) number K212516. 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 IRNF App?

IRNF App is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Apple, Inc.. The 510(k) number is K212516.

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

IRNF App received FDA 510(k) clearance on 2021-10-22, under 510(k) number K212516.

Who is the listed applicant for IRNF 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 IRNF App?

The FDA product code for IRNF App is QDB.

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：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.K212372Fitbit 不規則節律通知Fitbit, Inc.

官方來源

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