The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Liberty Cycler.
| Device ID | K043363 |
| 510k Number | K043363 |
| Device Name: | FRESENIUS LIBERTY CYCLER |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Contact | Arthur Eilinsfeld |
| Correspondent | Arthur Eilinsfeld FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-07 |
| Decision Date | 2005-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840861100757 | K043363 | 000 |
| 10840861100740 | K043363 | 000 |
| 10840861100733 | K043363 | 000 |
| 10840861101112 | K043363 | 000 |