M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
K-Number: K171579 · 2017-10-18
Decision Date2017-10-18
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2017-10-18 under approval number K171579. 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 M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System?
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-10-18. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K171579.
When was M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System approved by the FDA?
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-10-18, under approval number K171579.
What company makes M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System?
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System?
The FDA product code for M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 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.