FDA 510(k)

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

Número K: K250228 · 2025-04-23

RequerenteEsonic Technology (Wuhan) Co., Ltd.

Data da decisão2025-04-23

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) is the device name listed in this FDA 510(k) record. The listed applicant is Esonic Technology (Wuhan) Co., Ltd.. It received FDA 510(k) clearance on 2025-04-23 under 510(k) number K250228. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Esonic Technology (Wuhan) Co., Ltd.. The 510(k) number is K250228.

When did eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) receive FDA 510(k) clearance?

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

Who is the listed applicant for eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)?

The FDA 510(k) record lists Esonic Technology (Wuhan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Outros registros que listam Esonic Technology (Wuhan) Co., Ltd. como candidato(a)

K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system

Dispositivos Relacionados (Código: IYN)

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