FDA 510(k)

eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)

K-Number: K250228 · 2025-04-23

ApplicantEsonic Technology (Wuhan) Co., Ltd.

Decision Date2025-04-23

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) is a medical device manufactured by Esonic Technology (Wuhan) Co., Ltd.. It received FDA 510(k) clearance on 2025-04-23 under approval number K250228. 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 eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)?

eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) is a medical device that received FDA 510(k) clearance on 2025-04-23. It is manufactured by Esonic Technology (Wuhan) Co., Ltd.. The 510(k) number is K250228.

When was eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) approved by the FDA?

eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) received FDA 510(k) clearance on 2025-04-23, under approval number K250228.

What company makes eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)?

eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) is manufactured by Esonic Technology (Wuhan) Co., Ltd..

What is the FDA product code for eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)?

The FDA product code for eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) is IYN.

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Official Source

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