GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H— 510(k) K093608

Name: FDA 510(k) clearance K093608
Creator: U.S. Food and Drug Administration
Published: 2010-07-29

Substantially Equivalent

Gambro Renal Products, Inc.

FDA 510(k) clearance K093608 for GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H, Substantially Equivalent on 2010-07-29. Applicant: Gambro Renal Products, Inc.. Device class: 2.

Clearance details

Applicant: Gambro Renal Products, Inc.
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2009-11-20
Decision date: 2010-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
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.