The following data is part of a premarket notification filed by Fresenius Medical Care, North America with the FDA for Fresenius 2008t Hemodialysis Machine With Bibag System.
| Device ID | K121341 |
| 510k Number | K121341 |
| Device Name: | FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | FRESENIUS MEDICAL CARE, NORTH AMERICA 920 WINTER STREET Waltham, MA 01854 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann FRESENIUS MEDICAL CARE, NORTH AMERICA 920 WINTER STREET Waltham, MA 01854 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-03 |
| Decision Date | 2012-12-06 |
| Summary: | summary |