FDA 510(k)

Leltek 超声成像系统

K号: K191235 · 2020-02-12

决定日期2020-02-12

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Leltek Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Leltek, Inc.. It received FDA 510(k) clearance on 2020-02-12 under 510(k) number K191235. 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 Leltek Ultrasound Imaging System?

Leltek Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-02-12. The listed applicant is Leltek, Inc.. The 510(k) number is K191235.

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

Leltek Ultrasound Imaging System received FDA 510(k) clearance on 2020-02-12, under 510(k) number K191235.

Who is the listed applicant for Leltek Ultrasound Imaging System?

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

What is the FDA product code for Leltek Ultrasound Imaging System?

The FDA product code for Leltek Ultrasound Imaging System is IYN.

列明Leltek, 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。

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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