FDA 510(k)

PixoTest Blood Glucose Monitoring System

K-Number: K163087 · 2017-11-02

Decision Date2017-11-02

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PixoTest Blood Glucose Monitoring System is a medical device manufactured by Ixensor Company , Ltd.. It received FDA 510(k) clearance on 2017-11-02 under approval number K163087. 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 PixoTest Blood Glucose Monitoring System?

PixoTest Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-11-02. It is manufactured by Ixensor Company , Ltd.. The 510(k) number is K163087.

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

PixoTest Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-11-02, under approval number K163087.

What company makes PixoTest Blood Glucose Monitoring System?

PixoTest Blood Glucose Monitoring System is manufactured by Ixensor Company , Ltd..

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

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

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Related Devices (Code: NBW)

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Official Source

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