The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Liberty Pdx Cycler.
| Device ID | K141145 |
| 510k Number | K141145 |
| Device Name: | LIBERTY PDX CYCLER |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 920 Winter Street Waltham, MA 02451 |
| Contact | Denise M Oppermann |
| Correspondent | Denise M Oppermann FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC 920 Winter Street Waltham, MA 02451 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-02 |
| Decision Date | 2014-07-30 |
| Summary: | summary |