FDA 510(k)

iGlucose Blood Glucose Monitoring System

K-Number: K161790 · 2017-05-02

Decision Date2017-05-02

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

iGlucose Blood Glucose Monitoring System is a medical device manufactured by Bionime Corporation. It received FDA 510(k) clearance on 2017-05-02 under approval number K161790. 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 iGlucose Blood Glucose Monitoring System?

iGlucose Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-05-02. It is manufactured by Bionime Corporation. The 510(k) number is K161790.

When was iGlucose Blood Glucose Monitoring System approved by the FDA?

iGlucose Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-05-02, under approval number K161790.

What company makes iGlucose Blood Glucose Monitoring System?

iGlucose Blood Glucose Monitoring System is manufactured by Bionime Corporation.

What is the FDA product code for iGlucose Blood Glucose Monitoring System?

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

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Other Devices by Bionime Corporation

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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.