FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
FDA 510(k) clearance K101715 · decided 2010-12-21
Clearance details
- K-number
- K101715
- Device name
- FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
- Applicant
- Fresenius Medical Care North America, Design Cente
- Decision
- Substantially Equivalent
- Date received
- 2010-06-18
- Decision date
- 2010-12-21
- Days to decision
- 186 days
- Clearance type
- Traditional
- 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 |