K080919 is an FDA 510(k) clearance for the NXSTAGE PUREFLOW SL. 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 October 15, 2008, 197 days after receiving the submission on April 1, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K080919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2008 |
| Decision Date | October 15, 2008 |
| Days to Decision | 197 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 |