FDA 510(k)

彩色多普勒超声系统；型号：mEye1和mEye2

K号: K182165 · 2018-12-20

申请人Shenzhen Well.D Medical Electronics Co., Ltd.

决定日期2018-12-20

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Color Doppler Ultrasound System; Model: mEye1 and mEye2 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Well.D Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K182165. 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 Color Doppler Ultrasound System; Model: mEye1 and mEye2?

Color Doppler Ultrasound System; Model: mEye1 and mEye2 is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Shenzhen Well.D Medical Electronics Co., Ltd.. The 510(k) number is K182165.

When did Color Doppler Ultrasound System; Model: mEye1 and mEye2 receive FDA 510(k) clearance?

Color Doppler Ultrasound System; Model: mEye1 and mEye2 received FDA 510(k) clearance on 2018-12-20, under 510(k) number K182165.

Who is the listed applicant for Color Doppler Ultrasound System; Model: mEye1 and mEye2?

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

What is the FDA product code for Color Doppler Ultrasound System; Model: mEye1 and mEye2?

The FDA product code for Color Doppler Ultrasound System; Model: mEye1 and mEye2 is IYN.

相关器械（代码：IYN）

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器械摘要

常见问题

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相关器械（代码：IYN）

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