The following data is part of a premarket notification filed by Nxstage Medical, Inc with the FDA for Nxstage Connected Health System.
| Device ID | K181991 |
| 510k Number | K181991 |
| Device Name: | NxStage Connected Health System |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | NxStage Medical, Inc 350 Merrimack Street Lawrence, MA 01843 |
| Contact | Christina Marabella |
| Correspondent | Christina Marabella NxStage Medical, Inc 350 Merrimack Street Lawrence, MA 01843 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-26 |
| Decision Date | 2018-09-26 |
| Summary: | summary |