THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)— 510(k) K061328

Substantially Equivalent

E-San Limited

FDA 510(k) clearance K061328 for THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM), Substantially Equivalent on 2006-06-13. Applicant: E-San Limited.

Clearance details

Applicant: E-San Limited
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2006-05-12
Decision date: 2006-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.