2008K2 Hemodialysis Machine
FDA 510(k) clearance K153449 · decided 2016-04-26
Clearance details
- K-number
- K153449
- Device name
- 2008K2 Hemodialysis Machine
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-11-30
- Decision date
- 2016-04-26
- Days to decision
- 148 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 |
|---|---|---|
| 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/ recall (Z-1278-2018) | Fresenius Medical Care Renal Therapies Group, LLC | 2018-03-20 |