FDA 510(k)

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System

N.º K: K161359 · 2016-07-19

Fecha de decisión2016-07-19

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-07-19 under 510(k) number K161359. 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 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System?

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-07-19. The listed applicant is Esaote, S.p.A.. The 510(k) number is K161359.

When did 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System receive FDA 510(k) clearance?

6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System received FDA 510(k) clearance on 2016-07-19, under 510(k) number K161359.

Who is the listed applicant for 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System?

The FDA product code for 6400 Ultrasound System,7400 Ultrasound System, 7410 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 Esaote, S.p.A. como solicitante

K261331I-Genius (100019400)K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

Ver todos los 25 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.