510(k) K052817— EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF

Substantially Equivalent

Universal Medical Technologies

Clearance details

Applicant: Universal Medical Technologies
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2005-10-04
Decision date: 2006-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Larkspur, 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.