K060296 is an FDA 510(k) clearance for the NXSTAGE DIALYSATE PREPARATION MODULE. 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 31, 2006, 53 days after receiving the submission on February 6, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K060296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2006 |
| Decision Date | March 31, 2006 |
| Days to Decision | 53 days |
| Submission Type | Special |
| 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 |