FDA 510(k)

Sistema de Ultrasonido Apache

N.º K: K211232 · 2021-06-25

Fecha de decisión2021-06-25

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K231509Sistema de ultrasonido Aco Apache

Dispositivos relacionados (Código: IYN)

Fuente oficial

Ver en la base de datos de la FDA →

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