FDA 510(k)

EasyMax BT Self-Monitoring Blood Glucose System

Número K: K182057 · 2018-08-24

Data da decisão2018-08-24

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

EasyMax BT Self-Monitoring Blood Glucose System is the device name listed in this FDA 510(k) record. The listed applicant is Eps Bio Technology Corp.. It received FDA 510(k) clearance on 2018-08-24 under 510(k) number K182057. 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 EasyMax BT Self-Monitoring Blood Glucose System?

EasyMax BT Self-Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K182057.

When did EasyMax BT Self-Monitoring Blood Glucose System receive FDA 510(k) clearance?

EasyMax BT Self-Monitoring Blood Glucose System received FDA 510(k) clearance on 2018-08-24, under 510(k) number K182057.

Who is the listed applicant for EasyMax BT Self-Monitoring Blood Glucose System?

The FDA 510(k) record lists Eps Bio Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyMax BT Self-Monitoring Blood Glucose System?

The FDA product code for EasyMax BT Self-Monitoring Blood Glucose System is NBW. This falls under the OB/GYN category.

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