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 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 2021-09-01 under 510(k) 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. The listed applicant is Eps Bio Technology Corp.. The 510(k) number is K201258.

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

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

Who is the listed applicant for EASYMAX Tag 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 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05081037Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)ACTIVE_NOT_RECRUITING NCT05947916Real Time Continuous Glucose Monitoring System in T2DM With PregnacyRECRUITING NCT06310356Continuous Glucose Monitoring for Women With Gestational DiabetesRECRUITING NCT06572306Pharmacist-led Continuous Glucose MonitoringRECRUITING NCT06587438Effect of CGM on Glucose Control in Non-insulin-treated Patients With Type 2 Diabetes MellitusACTIVE_NOT_RECRUITING NCT06628453CGM for Management of Type 2 Diabetes in PregnancyRECRUITING

Other records listing Eps Bio Technology Corp. as applicant

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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.