510(k) K002739— INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K

Substantially Equivalent

Baxter Healthcare Corp

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code MEA
Advisory panel: General Hospital
Date received: 2000-09-01
Decision date: 2000-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Lake, IL, 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.