FDA 510(k)

Pocket Ultrasound System (C10)

Número K: K231354 · 2023-12-20

RequerenteBeijing Konted Medical Technology Co.,Ltd

Data da decisão2023-12-20

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pocket Ultrasound System (C10) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231354. 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 Pocket Ultrasound System (C10)?

Pocket Ultrasound System (C10) is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Beijing Konted Medical Technology Co.,Ltd. The 510(k) number is K231354.

When did Pocket Ultrasound System (C10) receive FDA 510(k) clearance?

Pocket Ultrasound System (C10) received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231354.

Who is the listed applicant for Pocket Ultrasound System (C10)?

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

What is the FDA product code for Pocket Ultrasound System (C10)?

The FDA product code for Pocket Ultrasound System (C10) is IYN.

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Outros registros que listam Beijing Konted Medical Technology Co.,Ltd como candidato(a)

K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

Dispositivos Relacionados (Código: IYN)

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