FRESENIUS 2008K
FDA 510(k) clearance K994267 · decided 2000-03-16
Clearance details
- K-number
- K994267
- Device name
- FRESENIUS 2008K
- Applicant
- Fresenius Medical Care
- Decision
- Substantially Equivalent
- Date received
- 1999-12-17
- Decision date
- 2000-03-16
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 2008 Series Hemodialysis Machines: 2008K with the following product code and description: recall (Z-1551-2015) | Fresenius Medical Care Holdings, Inc. | 2015-04-29 |
| 2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: recall (Z-1552-2015) | Fresenius Medical Care Holdings, Inc. | 2015-04-29 |
| ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T He recall (Z-1015-2015) | Fresenius Medical Care Holdings, Inc. | 2015-01-27 |
| 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 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius recall (Z-2225-2010) | Fresenius Medical Care North America | 2010-08-15 |