510(k) K060806— HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088

Substantially Equivalent

Hospira, Inc.

Clearance details

Applicant: Hospira, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2006-03-24
Decision date: 2006-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Forest, IL, US

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.