K140623 is an FDA 510(k) clearance for the NXSTAGE EXPRESS FLUID WARMER. This device is classified as a Monitor, Temperature, Dialysis (Class II - Special Controls, product code FLA).
Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on June 16, 2014, 97 days after receiving the submission on March 11, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K140623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2014 |
| Decision Date | June 16, 2014 |
| Days to Decision | 97 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FLA — Monitor, Temperature, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |