FDA 510(k)

艾默里心臟工具箱 4.3

K 號：K223422 · 2023-03-30

決定日期2023-03-30

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

Emory Cardiac Toolbox 4.3 is the device name listed in this FDA 510(k) record. The listed applicant is Syntermed. It received FDA 510(k) clearance on 2023-03-30 under 510(k) number K223422. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Emory Cardiac Toolbox 4.3?

Emory Cardiac Toolbox 4.3 is a medical device that received FDA 510(k) clearance on 2023-03-30. The listed applicant is Syntermed. The 510(k) number is K223422.

When did Emory Cardiac Toolbox 4.3 receive FDA 510(k) clearance?

Emory Cardiac Toolbox 4.3 received FDA 510(k) clearance on 2023-03-30, under 510(k) number K223422.

Who is the listed applicant for Emory Cardiac Toolbox 4.3?

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

What is the FDA product code for Emory Cardiac Toolbox 4.3?

The FDA product code for Emory Cardiac Toolbox 4.3 is KPS.

其他以 Syntermed 為申請人之記錄

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K180077神經Q 3.8

相關器械（代碼：KPS）

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。

官方來源

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