K090002

Substantially Equivalent

ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A

Applicant: Baxter Healthcare Corp
Product code: KPO
Advisory panel: Gastroenterology, Urology
Date received: 2009-01-02
Decision date: 2009-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.