FDA 510(k)

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system

N.º K: K213131 · 2023-08-10

Fecha de decisión2023-08-10

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care GmbH. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K213131. 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 Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Roche Diabetes Care GmbH. The 510(k) number is K213131.

When did Accu-Chek Guide Solo diabetes manager blood glucose monitoring system receive FDA 510(k) clearance?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system received FDA 510(k) clearance on 2023-08-10, under 510(k) number K213131.

Who is the listed applicant for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

The FDA 510(k) record lists Roche Diabetes Care GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

The FDA product code for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is NBW. This falls under the OB/GYN category.

Ensayos clínicos relacionados

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Otros registros que enlistan a Roche Diabetes Care GmbH como solicitante

K213134Sistema de bomba micropump Accu-Chek Solo con tecnología interoperable

Dispositivos relacionados (Código: NBW)

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Fuente oficial

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