The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for 2008t Bluestar Hemodailysis Machine.
| Device ID | K222952 |
| 510k Number | K222952 |
| Device Name: | 2008T BlueStar Hemodailysis Machine |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Contact | Denise M Oppermann |
| Correspondent | Denise M Oppermann Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-27 |
| Decision Date | 2022-10-27 |