FDA 510(k)

GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

K-Number: K032985 · 2003-10-21

Decision Date2003-10-21

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hmd Biomedical, Inc.. It received FDA 510(k) clearance on 2003-10-21 under 510(k) number K032985. 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 GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM?

GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-21. The listed applicant is Hmd Biomedical, Inc.. The 510(k) number is K032985.

When did GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM receive FDA 510(k) clearance?

GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM received FDA 510(k) clearance on 2003-10-21, under 510(k) number K032985.

Who is the listed applicant for GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM?

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

What is the FDA product code for GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM?

The FDA product code for GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM is NBW. This falls under the OB/GYN category.

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Other records listing Hmd Biomedical, Inc. as applicant

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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.