The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for 2008t Hemodialysis Machine With Optional Crit-line Monitor (clic).
| Device ID | K131908 |
| 510k Number | K131908 |
| Device Name: | 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) |
| 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 | 2013-06-26 |
| Decision Date | 2013-10-11 |
| Summary: | summary |