FDA 510(k)

OneTouch Verio Reflect Blood Glucose Monitoring System

N.º K: K193475 · 2020-02-14

Fecha de decisión2020-02-14

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

OneTouch Verio Reflect Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan Europe GmbH. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K193475. 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 OneTouch Verio Reflect Blood Glucose Monitoring System?

OneTouch Verio Reflect Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Lifescan Europe GmbH. The 510(k) number is K193475.

When did OneTouch Verio Reflect Blood Glucose Monitoring System receive FDA 510(k) clearance?

OneTouch Verio Reflect Blood Glucose Monitoring System received FDA 510(k) clearance on 2020-02-14, under 510(k) number K193475.

Who is the listed applicant for OneTouch Verio Reflect Blood Glucose Monitoring System?

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

What is the FDA product code for OneTouch Verio Reflect Blood Glucose Monitoring System?

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

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