FDA 510(k)

One Drop Blood Glucose Monitoring System

Número K: K161834 · 2016-11-30

Data da decisão2016-11-30

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

One Drop Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Agamatrix, Inc.. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K161834. 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 One Drop Blood Glucose Monitoring System?

One Drop Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Agamatrix, Inc.. The 510(k) number is K161834.

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

One Drop Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-11-30, under 510(k) number K161834.

Who is the listed applicant for One Drop Blood Glucose Monitoring System?

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

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

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

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