K090245

Substantially Equivalent

SOLO INSULIN PATCH PUMP

Applicant: Medingo , Ltd.
Product code: LZG
Advisory panel: General Hospital
Date received: 2009-02-02
Decision date: 2009-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yoqneam, IL

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.