510(k) K042797— WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Substantially Equivalent

Gambro Renal Products

Clearance details

Applicant: Gambro Renal Products
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 2004-10-08
Decision date: 2005-03-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lakewood, CO, US

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

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.