FDA 510(k)

Emory 心脏工具箱 4.3

K号: K223422 · 2023-03-30

决定日期2023-03-30

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Syntermed为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K180077NeuroQ 3.8

相关器械（代码：KPS）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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