FDA 510(k)

MDT2 BLE Self-Monitoring Blood Glucose System

Número K: K190189 · 2019-11-01

Data da decisão2019-11-01

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

MDT2 BLE 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 2019-11-01 under 510(k) number K190189. 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 MDT2 BLE Self-Monitoring Blood Glucose System?

MDT2 BLE Self-Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K190189.

When did MDT2 BLE Self-Monitoring Blood Glucose System receive FDA 510(k) clearance?

MDT2 BLE Self-Monitoring Blood Glucose System received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190189.

Who is the listed applicant for MDT2 BLE 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 MDT2 BLE Self-Monitoring Blood Glucose System?

The FDA product code for MDT2 BLE Self-Monitoring Blood Glucose System is NBW. This falls under the OB/GYN category.

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