FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS— 510(k) K002761
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K002761 for FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS, Substantially Equivalent on 2000-12-04. Applicant: Fresenius Medical Care North America.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code FJI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Adverse events under product code FJI
product code FJI- Death
- 2
- Total
- 2
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.