The following data is part of a premarket notification filed by Fresenius Medical Care North America, Design Cente with the FDA for Fresenius 2008t Hemodialysis Machine Model 190573.
| Device ID | K101715 |
| 510k Number | K101715 |
| Device Name: | FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 Winter Street Waltham, MA 02451 -1457 |
| Contact | Randolph Quinn |
| Correspondent | Randolph Quinn FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE 920 Winter Street Waltham, MA 02451 -1457 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-18 |
| Decision Date | 2010-12-21 |
| Summary: | summary |