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

Name: FDA 510(k) clearance K042797
Creator: U.S. Food and Drug Administration
Published: 2005-03-09

Substantially Equivalent

Gambro Renal Products

FDA 510(k) clearance K042797 for WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS, Substantially Equivalent on 2005-03-09. Applicant: Gambro Renal Products. Device class: 2.

Clearance details

Applicant: Gambro Renal Products
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2004-10-08
Decision date: 2005-03-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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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.