TE7/TE5 Diagnostic Ultrasound System
K-Number: K180912 · 2018-07-30
Decision Date2018-07-30
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TE7/TE5 Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-07-30 under approval number K180912. 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/TE5 Diagnostic Ultrasound System?
TE7/TE5 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-07-30. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K180912.
When was TE7/TE5 Diagnostic Ultrasound System approved by the FDA?
TE7/TE5 Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-07-30, under approval number K180912.
What company makes TE7/TE5 Diagnostic Ultrasound System?
TE7/TE5 Diagnostic Ultrasound System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for TE7/TE5 Diagnostic Ultrasound System?
The FDA product code for TE7/TE5 Diagnostic Ultrasound System is IYN.
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Other Devices by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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Related Devices (Code: IYN)
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K163020Xperius Ultrasound SystemPhilips Health Care
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.