K181991 is an FDA 510(k) clearance for the NxStage Connected Health System. This device is classified as a System, Dialysate Delivery, Single Patient (Class II - Special Controls, product code FKP).
Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on September 26, 2018, 62 days after receiving the submission on July 26, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K181991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2018 |
| Decision Date | September 26, 2018 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKP — System, Dialysate Delivery, Single Patient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |