Z6 Diagnostic Ultrasound System
K-Number: K182603 · 2018-11-14
Decision Date2018-11-14
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Z6 Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-11-14 under approval number K182603. 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 Z6 Diagnostic Ultrasound System?
Z6 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-11-14. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K182603.
When was Z6 Diagnostic Ultrasound System approved by the FDA?
Z6 Diagnostic Ultrasound System received FDA 510(k) clearance on 2018-11-14, under approval number K182603.
What company makes Z6 Diagnostic Ultrasound System?
Z6 Diagnostic Ultrasound System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for Z6 Diagnostic Ultrasound System?
The FDA product code for Z6 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.