FDA 510(k)

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System

K-Number: K152365 · 2016-04-21

Decision Date2016-04-21

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is a medical device manufactured by Agamatrix, Inc.. It received FDA 510(k) clearance on 2016-04-21 under approval number K152365. 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 AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System?

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-04-21. It is manufactured by Agamatrix, Inc.. The 510(k) number is K152365.

When was AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System approved by the FDA?

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-04-21, under approval number K152365.

What company makes AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System?

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is manufactured by Agamatrix, Inc..

What is the FDA product code for AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System?

The FDA product code for AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Other Devices by Agamatrix, Inc.

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Related Devices (Code: NBW)

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Official Source

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