FDA 510(k)

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System

K号: K161525 · 2016-07-13

申请人Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

决定日期2016-07-13

产品代码IYN

咨询委员会RA

决定Substantially Equivalent

器械摘要

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K161525. 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 TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System?

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K161525.

When did TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System receive FDA 510(k) clearance?

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-07-13, under 510(k) number K161525.

Who is the listed applicant for TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System?

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

What is the FDA product code for TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System?

The FDA product code for TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System is IYN.

列明Shenzhen Mindray Bio-Medical Electronics Co., Ltd.为申报人的其他记录

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相关器械（代码：IYN）

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