K944767 is an FDA 510(k) clearance for the DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER, a Subsystem, Water Purification (Class II — Special Controls, product code FIP), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on November 29, 1995, 428 days after receiving the submission on September 27, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K944767 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 1994 |
| Decision Date | November 29, 1995 |
| Days to Decision | 428 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIP — Subsystem, Water Purification |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5665 |