FDA 510(k)

EASYMAX Tag Self-Monitoring Blood Glucose System

K-Number: K201258 · 2021-09-01

Decision Date2021-09-01

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EASYMAX Tag Self-Monitoring Blood Glucose System is a medical device manufactured by Eps Bio Technology Corp.. It received FDA 510(k) clearance on 2021-09-01 under approval number K201258. 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 Tag Self-Monitoring Blood Glucose System?

EASYMAX Tag Self-Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2021-09-01. It is manufactured by Eps Bio Technology Corp.. The 510(k) number is K201258.

When was EASYMAX Tag Self-Monitoring Blood Glucose System approved by the FDA?

EASYMAX Tag Self-Monitoring Blood Glucose System received FDA 510(k) clearance on 2021-09-01, under approval number K201258.

What company makes EASYMAX Tag Self-Monitoring Blood Glucose System?

EASYMAX Tag Self-Monitoring Blood Glucose System is manufactured by Eps Bio Technology Corp..

What is the FDA product code for EASYMAX Tag Self-Monitoring Blood Glucose System?

The FDA product code for EASYMAX Tag 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)

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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.