FRESENIUS 2008T HEMODIALYSIS MACHINE— 510(k) K111639
Substantially EquivalentFresenius Medical Care
FDA 510(k) clearance K111639 for FRESENIUS 2008T HEMODIALYSIS MACHINE, Substantially Equivalent on 2011-10-21. Applicant: Fresenius Medical Care. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care
- 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
- Special
- Location
- Waltham, MA, US
Recent devices under product code KDI
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view all- K231534 — 5008X Hemodialysis System
- K141997 — CRIT-LINE IV SYSTEM
- K030497 — FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
- K023162 — FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
- K022536 — \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
Adverse 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 K111639
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 K111639.
Data sourced from openFDA. This site is unofficial and independent of the FDA.