FDA 510(k)

GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE

K-Number: K082486 · 2008-10-08

Decision Date2008-10-08

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2008-10-08 under 510(k) number K082486. 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 GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE?

GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K082486.

When did GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE receive FDA 510(k) clearance?

GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE received FDA 510(k) clearance on 2008-10-08, under 510(k) number K082486.

Who is the listed applicant for GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE?

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

What is the FDA product code for GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE?

The FDA product code for GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE 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.