K032147

Substantially Equivalent

SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES

Applicant: Alaris Medical Systems, Inc.
Product code: FRN
Advisory panel: General Hospital
Date received: 2003-07-14
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.