FDA 510(k)

On Call Express II Blood Glucose Monitoring System

Número K: K192175 · 2019-10-17

Data da decisão2019-10-17

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

On Call Express II 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 2019-10-17 under 510(k) number K192175. 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.

Perguntas frequentes

What is the On Call Express II Blood Glucose Monitoring System?

On Call Express II Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K192175.

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

On Call Express II Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-10-17, under 510(k) number K192175.

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

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

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