FDA 510(k)

MDT2 BLE Self-Monitoring Blood Glucose System

K-Number: K190189 · 2019-11-01

Decision Date2019-11-01

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MDT2 BLE Self-Monitoring Blood Glucose System is a medical device manufactured by Eps Bio Technology Corp.. It received FDA 510(k) clearance on 2019-11-01 under approval 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.

Frequently Asked Questions

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. It is manufactured by Eps Bio Technology Corp.. The 510(k) number is K190189.

When was MDT2 BLE Self-Monitoring Blood Glucose System approved by the FDA?

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

What company makes MDT2 BLE Self-Monitoring Blood Glucose System?

MDT2 BLE Self-Monitoring Blood Glucose System is manufactured by Eps Bio Technology Corp..

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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Other Devices by Eps Bio Technology Corp.

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Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.