FDA 510(k)

Coala 心臟監護儀

K 號：K182040 · 2019-02-08

決定日期2019-02-08

產品代碼DXH

諮詢委員會履歷

決定相當於

器材摘要

Coala Heart Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Coala Life AB. It received FDA 510(k) clearance on 2019-02-08 under 510(k) number K182040. 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 Coala Heart Monitor?

Coala Heart Monitor is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Coala Life AB. The 510(k) number is K182040.

When did Coala Heart Monitor receive FDA 510(k) clearance?

Coala Heart Monitor received FDA 510(k) clearance on 2019-02-08, under 510(k) number K182040.

Who is the listed applicant for Coala Heart Monitor?

The FDA 510(k) record lists Coala Life AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coala Heart Monitor?

The FDA product code for Coala Heart Monitor is DXH. This falls under the Hematology category.

其他以 Coala Life AB 為申請人之記錄

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K212163Coala 心臟監護儀

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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