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FDA 510(k)

Full Digital Colour Doppler Ultrasonic Diagnostic System

K-Number: K183041 · 2019-07-10

ApplicantWuhan Zoncare Bio-medical Electronics Co., Ltd.
Decision Date2019-07-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Full Digital Colour Doppler Ultrasonic Diagnostic System is a medical device manufactured by Wuhan Zoncare Bio-medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-07-10 under approval number K183041. 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 Full Digital Colour Doppler Ultrasonic Diagnostic System?

Full Digital Colour Doppler Ultrasonic Diagnostic System is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by Wuhan Zoncare Bio-medical Electronics Co., Ltd.. The 510(k) number is K183041.

When was Full Digital Colour Doppler Ultrasonic Diagnostic System approved by the FDA?

Full Digital Colour Doppler Ultrasonic Diagnostic System received FDA 510(k) clearance on 2019-07-10, under approval number K183041.

What company makes Full Digital Colour Doppler Ultrasonic Diagnostic System?

Full Digital Colour Doppler Ultrasonic Diagnostic System is manufactured by Wuhan Zoncare Bio-medical Electronics Co., Ltd..

What is the FDA product code for Full Digital Colour Doppler Ultrasonic Diagnostic System?

The FDA product code for Full Digital Colour Doppler Ultrasonic Diagnostic System is IYN.

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Related PubMed Literature

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Official Source

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