K043436 is an FDA 510(k) clearance for the NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269. This device is classified as a Subsystem, Proportioning (Class II - Special Controls, product code FKR).
Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on March 17, 2005, 94 days after receiving the submission on December 13, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K043436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2004 |
| Decision Date | March 17, 2005 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKR — Subsystem, Proportioning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |