Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
K-Number: K200411 · 2020-04-08
Decision Date2020-04-08
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-04-08 under approval number K200411. 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/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System?
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-04-08. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K200411.
When was Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System approved by the FDA?
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System received FDA 510(k) clearance on 2020-04-08, under approval number K200411.
What company makes Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System?
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System?
The FDA product code for Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 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.