FDA 510(k)

On Call Express Mobile Blood Glucose Monitoring System

N.º K: K180196 · 2018-03-07

Fecha de decisión2018-03-07

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

On Call Express Mobile Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2018-03-07 under 510(k) number K180196. 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 On Call Express Mobile Blood Glucose Monitoring System?

On Call Express Mobile Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-03-07. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K180196.

When did On Call Express Mobile Blood Glucose Monitoring System receive FDA 510(k) clearance?

On Call Express Mobile Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-03-07, under 510(k) number K180196.

Who is the listed applicant for On Call Express Mobile Blood Glucose Monitoring System?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for On Call Express Mobile Blood Glucose Monitoring System?

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

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