FDA 510(k)

LOGIQ e

K号: K232186 · 2023-11-03

申请人Ge Medical Systems Ultrasound and Primary Care Diagnostic,

决定日期2023-11-03

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

LOGIQ e is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K232186. 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 LOGIQ e?

LOGIQ e is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Diagnostic,. The 510(k) number is K232186.

When did LOGIQ e receive FDA 510(k) clearance?

LOGIQ e received FDA 510(k) clearance on 2023-11-03, under 510(k) number K232186.

Who is the listed applicant for LOGIQ e?

The FDA 510(k) record lists Ge Medical Systems Ultrasound and Primary Care Diagnostic, as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOGIQ e?

The FDA product code for LOGIQ e is IYN.

列明Ge Medical Systems Ultrasound and Primary Care Diagnostic,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。

K231989LOGIQ E10s, LOGIQ Fortis

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。