FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573— 510(k) K101715
Substantially EquivalentFresenius Medical Care North America, Design Cente
FDA 510(k) clearance K101715 for FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573, Substantially Equivalent on 2010-12-21. Applicant: Fresenius Medical Care North America, Design Cente. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America, Design Cente
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code KDI
view allMore clearances from Fresenius Medical Care North America, Design Cente
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
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 →
Recalls naming K101715
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101715.
Data sourced from openFDA. This site is unofficial and independent of the FDA.