The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Model 2008t Hemodialysis Machine.
| Device ID | K080964 |
| 510k Number | K080964 |
| Device Name: | FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Contact | Janet C Kay |
| Correspondent | Janet C Kay FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451 -1457 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-04 |
| Decision Date | 2009-01-14 |
| Summary: | summary |