The following data is part of a premarket notification filed by Fresenius Medical Care North America, Design Cente with the FDA for Fresenius Liberty Cycler.
| Device ID | K123630 |
| 510k Number | K123630 |
| Device Name: | FRESENIUS LIBERTY CYCLER |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 WINTER ST Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 WINTER ST 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 | 2012-11-23 |
| Decision Date | 2013-09-09 |
| Summary: | summary |