FDA 510(k)

KardiaMobile 心臟電圖設備

K 號：K211668 · 2021-11-30

決定日期2021-11-30

產品代碼DXH

諮詢委員會履歷

決定相當於

器材摘要

KardiaMobile Card is the device name listed in this FDA 510(k) record. The listed applicant is AliveCor, Inc.. It received FDA 510(k) clearance on 2021-11-30 under 510(k) number K211668. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the KardiaMobile Card?

KardiaMobile Card is a medical device that received FDA 510(k) clearance on 2021-11-30. The listed applicant is AliveCor, Inc.. The 510(k) number is K211668.

When did KardiaMobile Card receive FDA 510(k) clearance?

KardiaMobile Card received FDA 510(k) clearance on 2021-11-30, under 510(k) number K211668.

Who is the listed applicant for KardiaMobile Card?

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

What is the FDA product code for KardiaMobile Card?

The FDA product code for KardiaMobile Card is DXH. This falls under the Hematology category.

其他以 AliveCor, 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。

K252589科瓦伊爾蒙扎 K231010科瓦伊爾 K232035伊帕拉 K220350KardiaMobile 6L K212662AliveCor QT 服務 K210753KardiaMobile 6L

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相關器械（代碼：DXH）

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。

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官方來源

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