MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
FDA 510(k) clearance K093902 · decided 2010-05-27
Clearance details
- K-number
- K093902
- Device name
- MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2009-12-22
- Decision date
- 2010-05-27
- Days to decision
- 156 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 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 200 recall (Z-0629-2014) | Fresenius Medical Care Holdings, Inc. | 2014-01-06 |
| 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 |