K992015

Substantially Equivalent

FREEDOM INFUSION SYSTEM

Applicant: Novacon Corp.
Product code: MEB
Advisory panel: General Hospital
Date received: 1999-06-15
Decision date: 1999-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Elmo, MN, US

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.