FDA 510(k)

超声系统 2300

K号: K223830 · 2023-04-11

决定日期2023-04-11

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Ultrasound System 2300 is the device name listed in this FDA 510(k) record. The listed applicant is Bk Medical Aps. It received FDA 510(k) clearance on 2023-04-11 under 510(k) number K223830. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultrasound System 2300?

Ultrasound System 2300 is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Bk Medical Aps. The 510(k) number is K223830.

When did Ultrasound System 2300 receive FDA 510(k) clearance?

Ultrasound System 2300 received FDA 510(k) clearance on 2023-04-11, under 510(k) number K223830.

Who is the listed applicant for Ultrasound System 2300?

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

What is the FDA product code for Ultrasound System 2300?

The FDA product code for Ultrasound System 2300 is IYN.

列明Bk Medical Aps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。

K231764超声系统 1300 K222441超声系统 2300 K180737超声扫描系统 bk2300 K173569超声系统 1300 K161960bk2300

相关器械（代码：IYN）

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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