FRESENIUS LIBERTY CYCLER
FDA 510(k) clearance K123630 · decided 2013-09-09
Clearance details
- K-number
- K123630
- Device name
- FRESENIUS LIBERTY CYCLER
- Applicant
- Fresenius Medical Care North America, Design Cente
- Decision
- Substantially Equivalent
- Date received
- 2012-11-23
- Decision date
- 2013-09-09
- Days to decision
- 290 days
- Clearance type
- Traditional
- Product code
- FKX
- Device class
- 2
- Regulation number
- 876.5630
- 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 Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111 recall (Z-0693-2016) | Fresenius Medical Care Renal Therapies Group, LLC | 2016-01-27 |