TE Air Diagnostic Ultrasound System
K-Number: K231685 · 2023-10-26
Decision Date2023-10-26
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TE Air Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2023-10-26 under approval number K231685. 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 TE Air Diagnostic Ultrasound System?
TE Air Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-10-26. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K231685.
When was TE Air Diagnostic Ultrasound System approved by the FDA?
TE Air Diagnostic Ultrasound System received FDA 510(k) clearance on 2023-10-26, under approval number K231685.
What company makes TE Air Diagnostic Ultrasound System?
TE Air Diagnostic Ultrasound System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for TE Air Diagnostic Ultrasound System?
The FDA product code for TE Air 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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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.