DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS— 510(k) K082400
Substantially EquivalentCulligan Soft Water Service Co.
FDA 510(k) clearance K082400 for DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS, Substantially Equivalent on 2009-02-03. Applicant: Culligan Soft Water Service Co..
Clearance details
- Applicant
- Culligan Soft Water Service Co.
- Product code
- Code FIP
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, 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.