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FDA 510(k)

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound

K-Number: K172970 · 2017-10-25

Decision Date2017-10-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2017-10-25 under approval number K172970. 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 M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound?

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound is a medical device that received FDA 510(k) clearance on 2017-10-25. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K172970.

When was M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound approved by the FDA?

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound received FDA 510(k) clearance on 2017-10-25, under approval number K172970.

What company makes M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound?

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the FDA product code for M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound?

The FDA product code for M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound is IYN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.