FDA 510(k)

EasyMax BT Self-Monitoring Blood Glucose System

K-Number: K182057 · 2018-08-24

Decision Date2018-08-24

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EasyMax BT Self-Monitoring Blood Glucose System is a medical device manufactured by Eps Bio Technology Corp.. It received FDA 510(k) clearance on 2018-08-24 under approval 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.

Frequently Asked Questions

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. It is manufactured by Eps Bio Technology Corp.. The 510(k) number is K182057.

When was EasyMax BT Self-Monitoring Blood Glucose System approved by the FDA?

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

What company makes EasyMax BT Self-Monitoring Blood Glucose System?

EasyMax BT Self-Monitoring Blood Glucose System is manufactured by Eps Bio Technology Corp..

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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Related PubMed Literature

PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Other Devices by Eps Bio Technology Corp.

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Related Devices (Code: NBW)

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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.