The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Frsenius Pd Iqcard Cycler.
| Device ID | K002892 |
| 510k Number | K002892 |
| Device Name: | FRSENIUS PD IQCARD CYCLER |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02420 -9192 |
| Contact | Arthur Eilinsfeild |
| Correspondent | Arthur Eilinsfeild 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 | 2000-09-15 |
| Decision Date | 2001-04-05 |