K030470 is an FDA 510(k) clearance for the NXSTAGE SYSTEM ONE. This device is classified as a System, Dialysate Delivery, Sealed (Class II - Special Controls, product code FII).
Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on July 7, 2003, 145 days after receiving the submission on February 12, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K030470 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2003 |
| Decision Date | July 07, 2003 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FII — System, Dialysate Delivery, Sealed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |