FDA 510(k)

经颅多普勒超声系统

K号: K190228 · 2019-06-13

申请人Shenzhen Delica Medical Equipment Co., Ltd.

决定日期2019-06-13

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Transcranial Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Delica Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K190228. 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 Transcranial Doppler Ultrasound System?

Transcranial Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Shenzhen Delica Medical Equipment Co., Ltd.. The 510(k) number is K190228.

When did Transcranial Doppler Ultrasound System receive FDA 510(k) clearance?

Transcranial Doppler Ultrasound System received FDA 510(k) clearance on 2019-06-13, under 510(k) number K190228.

Who is the listed applicant for Transcranial Doppler Ultrasound System?

The FDA 510(k) record lists Shenzhen Delica Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcranial Doppler Ultrasound System?

The FDA product code for Transcranial Doppler Ultrasound System is IYN.

列明Shenzhen Delica Medical Equipment Co., Ltd.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。

K213009经颅多普勒超声系统 K173801经颅多普勒超声系统

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

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