FDA 510(k)

Apache超声系统

K号: K211232 · 2021-06-25

决定日期2021-06-25

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Apache Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Aco Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K211232. 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 Apache Ultrasound System?

Apache Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Aco Healthcare Co., Ltd.. The 510(k) number is K211232.

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

Apache Ultrasound System received FDA 510(k) clearance on 2021-06-25, under 510(k) number K211232.

Who is the listed applicant for Apache Ultrasound System?

The FDA 510(k) record lists Aco Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apache Ultrasound System?

The FDA product code for Apache Ultrasound System is IYN.

列明Aco Healthcare Co., Ltd.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。

K231509Aco Apache超声系统

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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