FDA 510(k)

GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020

K-Number: K022545 · 2002-10-11

Decision Date2002-10-11

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 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 2002-10-11 under 510(k) number K022545. 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 GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020?

GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 is a medical device that received FDA 510(k) clearance on 2002-10-11. The listed applicant is Hypoguard USA, Inc.. The 510(k) number is K022545.

When did GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 receive FDA 510(k) clearance?

GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 received FDA 510(k) clearance on 2002-10-11, under 510(k) number K022545.

Who is the listed applicant for GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020?

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 GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020?

The FDA product code for GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 is NBW. This falls under the OB/GYN category.

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Other records listing Hypoguard USA, Inc. as applicant

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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.