TE7 Diagnostic Ultrasound System
K-Number: K160381 · 2016-03-09
Decision Date2016-03-09
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TE7 Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-03-09 under approval number K160381. 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 System?
TE7 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-03-09. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K160381.
When was TE7 Diagnostic Ultrasound System approved by the FDA?
TE7 Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-03-09, under approval number K160381.
What company makes TE7 Diagnostic Ultrasound System?
TE7 Diagnostic Ultrasound System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for TE7 Diagnostic Ultrasound System?
The FDA product code for TE7 Diagnostic Ultrasound System is IYN.
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Other Devices by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
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K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
K160370BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)
K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
Related Devices (Code: IYN)
K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.
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K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics
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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.