PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)— 510(k) K994279
Substantially EquivalentPure Water Solutions, Inc.
FDA 510(k) clearance K994279 for PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION), Substantially Equivalent on 2000-12-22. Applicant: Pure Water Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Pure Water Solutions, Inc.
- Product code
- Code FIP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Englewood, CO, US
Recent devices under product code FIP
view allMore clearances from Pure Water Solutions, Inc.
view allAdverse 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.