FDA 510(k)

Sistema de ultrasonido Aco Apache

N.º K: K231509 · 2023-10-24

Fecha de decisión2023-10-24

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aco 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 2023-10-24 under 510(k) number K231509. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Aco Apache Ultrasound System?

Aco Apache Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Aco Healthcare Co., Ltd.. The 510(k) number is K231509.

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

Aco Apache Ultrasound System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K231509.

Who is the listed applicant for Aco 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 Aco Apache Ultrasound System?

The FDA product code for Aco Apache Ultrasound System is IYN.

Ensayos clínicos relacionados

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Otros registros que enlistan a Aco Healthcare Co., Ltd. como solicitante

K211232Sistema de Ultrasonido Apache

Dispositivos relacionados (Código: IYN)

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.