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FDA 510(k)

Dario Blood Glucose Monitoring System

N.º K: K163159 · 2017-07-19

SolicitanteLabstyle Innovations, Ltd.
Fecha de decisión2017-07-19
Código de productoNBW
Comité asesorCH
DecisiónSubstantially Equivalent

Resumen del dispositivo

Dario Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Labstyle Innovations, Ltd.. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K163159. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Dario Blood Glucose Monitoring System?

Dario Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Labstyle Innovations, Ltd.. The 510(k) number is K163159.

When did Dario Blood Glucose Monitoring System receive FDA 510(k) clearance?

Dario Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-07-19, under 510(k) number K163159.

Who is the listed applicant for Dario Blood Glucose Monitoring System?

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

What is the FDA product code for Dario Blood Glucose Monitoring System?

The FDA product code for Dario Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Dispositivos relacionados (Código: NBW)

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.

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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.

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