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FDA 510(k)

TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System

K-Number: K161525 · 2016-07-13

Decision Date2016-07-13
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 88 devices →

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.