DANA DIABECARE IIS— 510(k) K063126

Substantially Equivalent

Sooil Development Co., Ltd.

FDA 510(k) clearance K063126 for DANA DIABECARE IIS, Substantially Equivalent on 2007-02-02. Applicant: Sooil Development Co., Ltd..

Clearance details

Applicant: Sooil Development Co., Ltd.
Product code: Code LZG
Advisory panel: General Hospital
Date received: 2006-10-13
Decision date: 2007-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

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.