DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K-Number: K162845 · 2016-12-15
Decision Date2016-12-15
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-12-15 under approval number K162845. 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 DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System?
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K162845.
When was DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System approved by the FDA?
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-12-15, under approval number K162845.
What company makes DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System?
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System?
The FDA product code for DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is 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.