COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION— 510(k) K103396

Substantially Equivalent

I-Sens, Inc.

FDA 510(k) clearance K103396 for COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION, Substantially Equivalent on 2011-09-27. Applicant: I-Sens, Inc..

Clearance details

Applicant: I-Sens, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2010-11-19
Decision date: 2011-09-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Garden City, NY, US

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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.