The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for 2008t Bluestar Hemodialysis Machine.
| Device ID | K173972 |
| 510k Number | K173972 |
| Device Name: | 2008T BlueStar Hemodialysis 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 Oppermann |
| Correspondent | Denise 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 | 2017-12-29 |
| Decision Date | 2018-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861102112 | K173972 | 000 |
| 00840861102105 | K173972 | 000 |
| 00840861102099 | K173972 | 000 |
| 00840861102082 | K173972 | 000 |