GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H— 510(k) K093608
Substantially EquivalentGambro 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..
Clearance details
- Applicant
- Gambro Renal Products, Inc.
- Product code
- Code FIP
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Adverse events under product code FIP
product code FIP- Malfunction
- 490
- Total
- 490
Source: openFDA MAUDE database, through . 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.