510(k) K110535— ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION

Substantially Equivalent

Carefusion 303, Inc.

Clearance details

Applicant: Carefusion 303, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2011-02-25
Decision date: 2012-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
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.