FDA 510(k)

Kardia Band 系統

K 號：K171816 · 2017-11-16

決定日期2017-11-16

產品代碼DXH

諮詢委員會履歷

決定相當於

器材摘要

Kardia Band System is the device name listed in this FDA 510(k) record. The listed applicant is AliveCor, Inc.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K171816. 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 Kardia Band System?

Kardia Band System is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is AliveCor, Inc.. The 510(k) number is K171816.

When did Kardia Band System receive FDA 510(k) clearance?

Kardia Band System received FDA 510(k) clearance on 2017-11-16, under 510(k) number K171816.

Who is the listed applicant for Kardia Band System?

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 Kardia Band System?

The FDA product code for Kardia Band System is DXH. This falls under the Hematology category.

其他以 AliveCor, Inc. 為申請人之記錄

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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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