FDA 510(k)

LELTEK 超声成像系统（型号：LU700 系列）

K号: K210432 · 2021-11-03

决定日期2021-11-03

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 (Model: LU700 Series) is the device name listed in this FDA 510(k) record. The listed applicant is Leltek, Inc.. It received FDA 510(k) clearance on 2021-11-03 under 510(k) number K210432. 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 (Model: LU700 Series)?

LELTEK Ultrasound Imaging System (Model: LU700 Series) is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Leltek, Inc.. The 510(k) number is K210432.

When did LELTEK Ultrasound Imaging System (Model: LU700 Series) receive FDA 510(k) clearance?

LELTEK Ultrasound Imaging System (Model: LU700 Series) received FDA 510(k) clearance on 2021-11-03, under 510(k) number K210432.

Who is the listed applicant for LELTEK Ultrasound Imaging System (Model: LU700 Series)?

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 (Model: LU700 Series)?

The FDA product code for LELTEK Ultrasound Imaging System (Model: LU700 Series) is IYN.

列明Leltek, Inc.为申报人的其他记录

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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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