EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM— 510(k) K082521

Substantially Equivalent

Card Guard Scientific Survival , Ltd.

FDA 510(k) clearance K082521 for EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM, Substantially Equivalent on 2009-01-16. Applicant: Card Guard Scientific Survival , Ltd..

Clearance details

Applicant: Card Guard Scientific Survival , Ltd.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2008-09-02
Decision date: 2009-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

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.