FDA 510(k)

Sistema de Ultra-som Apache

Número K: K211232 · 2021-06-25

Data da decisão2021-06-25

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Apache Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Aco Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K211232. 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 Apache Ultrasound System?

Apache Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Aco Healthcare Co., Ltd.. The 510(k) number is K211232.

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

Apache Ultrasound System received FDA 510(k) clearance on 2021-06-25, under 510(k) number K211232.

Who is the listed applicant for Apache Ultrasound System?

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

What is the FDA product code for Apache Ultrasound System?

The FDA product code for Apache Ultrasound System is IYN.

Ensaios clínicos relacionados

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Outros registros que listam Aco Healthcare Co., Ltd. como candidato(a)

K231509Sistema de Ultrassonografia Aco Apache

Dispositivos Relacionados (Código: IYN)

Fonte oficial

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