FDA 510(k)

Apache超声系统（型号C62）

K号: K202074 · 2020-11-12

决定日期2020-11-12

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Apache Ultrasound System (Model C62) is the device name listed in this FDA 510(k) record. The listed applicant is Compal Electronics, Inc.. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K202074. 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 (Model C62)?

Apache Ultrasound System (Model C62) is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Compal Electronics, Inc.. The 510(k) number is K202074.

When did Apache Ultrasound System (Model C62) receive FDA 510(k) clearance?

Apache Ultrasound System (Model C62) received FDA 510(k) clearance on 2020-11-12, under 510(k) number K202074.

Who is the listed applicant for Apache Ultrasound System (Model C62)?

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

What is the FDA product code for Apache Ultrasound System (Model C62)?

The FDA product code for Apache Ultrasound System (Model C62) is IYN.

列明Compal Electronics, Inc.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。

K252078BreathePal Bilevel (GFM50-MD2201)K223135AblatePal 射频消融系统

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。