FDA 510(k)

OneTouch Via On-Demand Insulin Delivery System

N.º K: K163357 · 2017-06-07

SolicitanteLifescan Europe, A Division of Cilag GmbH

Fecha de decisión2017-06-07

Código de productoOPP

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

OneTouch Via On-Demand Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K163357. The device is classified under product code OPP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OneTouch Via On-Demand Insulin Delivery System?

OneTouch Via On-Demand Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. The 510(k) number is K163357.

When did OneTouch Via On-Demand Insulin Delivery System receive FDA 510(k) clearance?

OneTouch Via On-Demand Insulin Delivery System received FDA 510(k) clearance on 2017-06-07, under 510(k) number K163357.

Who is the listed applicant for OneTouch Via On-Demand Insulin Delivery System?

The FDA 510(k) record lists Lifescan Europe, A Division of Cilag GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OneTouch Via On-Demand Insulin Delivery System?

The FDA product code for OneTouch Via On-Demand Insulin Delivery System is OPP.

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

Dispositivos relacionados (Código: OPP)

K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA K243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA

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.