PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS— 510(k) K011005
Substantially EquivalentPure Water Solutions, Inc.
FDA 510(k) clearance K011005 for PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS, Substantially Equivalent on 2002-11-01. 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
- Traditional
- Location
- Jackson, MS, 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.