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FDA 510(k)

JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381

K-Number: K083265 · 2009-02-03

ApplicantAgamatrix, Inc.
Decision Date2009-02-03
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 is the device name listed in this FDA 510(k) record. The listed applicant is Agamatrix, Inc.. It received FDA 510(k) clearance on 2009-02-03 under 510(k) number K083265. 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 JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381?

JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 is a medical device that received FDA 510(k) clearance on 2009-02-03. The listed applicant is Agamatrix, Inc.. The 510(k) number is K083265.

When did JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 receive FDA 510(k) clearance?

JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 received FDA 510(k) clearance on 2009-02-03, under 510(k) number K083265.

Who is the listed applicant for JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381?

The FDA 510(k) record lists Agamatrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381?

The FDA product code for JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 is NBW. This falls under the OB/GYN category.

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Related Devices (Code: NBW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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