DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
K-Number: K182636 · 2019-01-10
Decision Date2019-01-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-01-10 under approval number K182636. 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-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System?
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-01-10. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K182636.
When was DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System approved by the FDA?
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-01-10, under approval number K182636.
What company makes DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System?
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System?
The FDA product code for DC-60/DC-60S/DC-60 Exp/DC-55 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.