HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE— 510(k) K041550

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K041550 for HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE, Substantially Equivalent on 2004-06-30. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2004-06-09
Decision date: 2004-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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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.