FDA 510(k)

WaveSense Jazz Blood Glucose Monitoring System

K-Number: K241304 · 2024-06-06

Decision Date2024-06-06

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

WaveSense Jazz Blood Glucose Monitoring System is a medical device manufactured by Agamatrix. It received FDA 510(k) clearance on 2024-06-06 under approval number K241304. 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 WaveSense Jazz Blood Glucose Monitoring System?

WaveSense Jazz Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2024-06-06. It is manufactured by Agamatrix. The 510(k) number is K241304.

When was WaveSense Jazz Blood Glucose Monitoring System approved by the FDA?

WaveSense Jazz Blood Glucose Monitoring System received FDA 510(k) clearance on 2024-06-06, under approval number K241304.

What company makes WaveSense Jazz Blood Glucose Monitoring System?

WaveSense Jazz Blood Glucose Monitoring System is manufactured by Agamatrix.

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

The FDA product code for WaveSense Jazz 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.