FDA 510(k)

U-Lite EXP

K号: K171164 · 2017-08-03

决定日期2017-08-03

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

U-Lite EXP is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscanner. It received FDA 510(k) clearance on 2017-08-03 under 510(k) number K171164. 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 U-Lite EXP?

U-Lite EXP is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Sonoscanner. The 510(k) number is K171164.

When did U-Lite EXP receive FDA 510(k) clearance?

U-Lite EXP received FDA 510(k) clearance on 2017-08-03, under 510(k) number K171164.

Who is the listed applicant for U-Lite EXP?

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

What is the FDA product code for U-Lite EXP?

The FDA product code for U-Lite EXP is IYN.

列明Sonoscanner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。

K201988T-Lite

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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