FDA 510(k)

LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067

K-Number: K052762 · 2006-01-23

Decision Date2006-01-23

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 is the device name listed in this FDA 510(k) record. The listed applicant is Agamatrix, Inc.. It received FDA 510(k) clearance on 2006-01-23 under 510(k) number K052762. 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 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067?

LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 is a medical device that received FDA 510(k) clearance on 2006-01-23. The listed applicant is Agamatrix, Inc.. The 510(k) number is K052762.

When did LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 receive FDA 510(k) clearance?

LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 received FDA 510(k) clearance on 2006-01-23, under 510(k) number K052762.

Who is the listed applicant for LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067?

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 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067?

The FDA product code for LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 is NBW. This falls under the OB/GYN category.

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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.