K111174 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 September 19, 2011, 145 days after receiving the submission on April 27, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K111174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2011 |
| Decision Date | September 19, 2011 |
| Days to Decision | 145 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 |