EASYGLUCO, MODEL IGM0002— 510(k) K031501

Substantially Equivalent

American Healthcare, Inc.

FDA 510(k) clearance K031501 for EASYGLUCO, MODEL IGM0002, Substantially Equivalent on 2003-10-16. Applicant: American Healthcare, Inc..

Clearance details

Applicant: American Healthcare, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2003-05-13
Decision date: 2003-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.