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FDA 510(k)

IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D

K-Number: K103544 · 2011-12-07

ApplicantAgamatrix, Inc.
Decision Date2011-12-07
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D is the device name listed in this FDA 510(k) record. The listed applicant is Agamatrix, Inc.. It received FDA 510(k) clearance on 2011-12-07 under 510(k) number K103544. 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 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D?

IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D is a medical device that received FDA 510(k) clearance on 2011-12-07. The listed applicant is Agamatrix, Inc.. The 510(k) number is K103544.

When did IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D receive FDA 510(k) clearance?

IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D received FDA 510(k) clearance on 2011-12-07, under 510(k) number K103544.

Who is the listed applicant for IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D?

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 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D?

The FDA product code for IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D is NBW. This falls under the OB/GYN category.

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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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