GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020— 510(k) K022545

Substantially Equivalent

Hypoguard USA, Inc.

FDA 510(k) clearance K022545 for GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020, Substantially Equivalent on 2002-10-11. Applicant: Hypoguard USA, Inc..

Clearance details

Applicant: Hypoguard USA, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2002-08-01
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.