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FDA 510(k)

MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K031388 · 2003-05-22

ApplicantHypoguard USA, Inc.
Decision Date2003-05-22
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hypoguard USA, Inc.. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K031388. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM?

MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Hypoguard USA, Inc.. The 510(k) number is K031388.

When did MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2003-05-22, under 510(k) number K031388.

Who is the listed applicant for MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM is CGA.

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Other records listing Hypoguard USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K053079ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001K051514ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002K041881ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100K033851DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)K024347EXPRESS BLOOD GLUCOSE MONITORING SYSTEMK022545GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020

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Related Devices (Code: CGA)

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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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