The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Dialysis Machine With Dialysate Ultrafilter.
| Device ID | K944767 |
| 510k Number | K944767 |
| Device Name: | DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER |
| Classification | Subsystem, Water Purification |
| Applicant | FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Contact | Scott N Walker |
| Correspondent | Scott N Walker FRESENIUS USA, INC. 2637 SHADELANDS DR. Walnut Creek, CA 94598 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1995-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04039361001391 | K944767 | 000 |