K130394

Substantially Equivalent

CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

Applicant: Smiths Medical Asd, Inc.
Product code: MEA
Advisory panel: General Hospital
Date received: 2013-02-15
Decision date: 2013-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Adverse events under product code MEA

product code MEA

Death: 19
Malfunction: 25,089
Total: 25,108

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.