FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
FDA 510(k) clearance K120017 · decided 2012-02-02
Clearance details
- K-number
- K120017
- Device name
- FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2012-01-03
- Decision date
- 2012-02-02
- Days to decision
- 30 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 |
|---|---|---|
| 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis thera recall (Z-0829-2018) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-02-20 |
| Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: recall (Z-1325-2016) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-05 |
| 2008 Series Hemodialysis Machines: 2008T with the following product code and description: recall (Z-1550-2015) | Fresenius Medical Care Holdings, Inc. | 2015-04-29 |