FDA 510(k)

HD80 Series Ultrasound Diagnostic System

Número K: K233841 · 2024-05-16

RequerenteQingdao Hisense Medical Equipment Co., Ltd.

Data da decisão2024-05-16

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

HD80 Series Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K233841. 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 HD80 Series Ultrasound Diagnostic System?

HD80 Series Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K233841.

When did HD80 Series Ultrasound Diagnostic System receive FDA 510(k) clearance?

HD80 Series Ultrasound Diagnostic System received FDA 510(k) clearance on 2024-05-16, under 510(k) number K233841.

Who is the listed applicant for HD80 Series Ultrasound Diagnostic System?

The FDA 510(k) record lists Qingdao Hisense Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HD80 Series Ultrasound Diagnostic System?

The FDA product code for HD80 Series Ultrasound Diagnostic System is IYN.

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Outros registros que listam Qingdao Hisense Medical Equipment Co., Ltd. como candidato(a)

K233439HD60 Series Ultrasound Diagnostic System K222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D K222132Hisense LCD monitor HMD2G21S, HMD3G21S K221567LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)K213862HD60 Series Ultrasound Diagnostic System K160347Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: IYN)

Fonte oficial

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