FDA 510(k)

ALOKA LISENDO 880

N.º K: K162583 · 2016-11-17

Fecha de decisión2016-11-17

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ALOKA LISENDO 880 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162583. 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 ALOKA LISENDO 880?

ALOKA LISENDO 880 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Hitachi , Ltd.. The 510(k) number is K162583.

When did ALOKA LISENDO 880 receive FDA 510(k) clearance?

ALOKA LISENDO 880 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162583.

Who is the listed applicant for ALOKA LISENDO 880?

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

What is the FDA product code for ALOKA LISENDO 880?

The FDA product code for ALOKA LISENDO 880 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 Hitachi , Ltd. como solicitante

K201042PROBEAT-CR K191801PROBEAT-CR K172087SANGRAY K163505ARIETTA PRECISION K162902ARIETTA Prologue Diagnostic Ultrasound system and Transducers K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

Ver todos los 7 dispositivos →

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.