GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE— 510(k) K083019

Substantially Equivalent

Hospira, Inc.

FDA 510(k) clearance K083019 for GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE, Substantially Equivalent on 2008-10-22. Applicant: Hospira, Inc..

Clearance details

Applicant: Hospira, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2008-10-09
Decision date: 2008-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

Download summary PDF View on FDA.gov ↗

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.