FRESENIUS 2008T HEMODIALYSIS MACHINE
FDA 510(k) clearance K111639 · decided 2011-10-21
Clearance details
- K-number
- K111639
- Device name
- FRESENIUS 2008T HEMODIALYSIS MACHINE
- Applicant
- Fresenius Medical Care
- Decision
- Substantially Equivalent
- Date received
- 2011-06-13
- Decision date
- 2011-10-21
- Days to decision
- 130 days
- Clearance type
- Special
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufa recall (Z-1693-2013) | Fresenius Medical Care Holdings, Inc. | 2013-07-11 |