The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage Connected Health System.
| Device ID | K131739 |
| 510k Number | K131739 |
| Device Name: | NXSTAGE CONNECTED HEALTH SYSTEM |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | NXSTAGE MEDICAL, INC. 350 Merrimack St Lawrence, MA 01843 |
| Contact | Mary Lou Stroumbos |
| Correspondent | Mary Lou Stroumbos NXSTAGE MEDICAL, INC. 350 Merrimack St 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 | 2013-06-13 |
| Decision Date | 2013-10-10 |
| Summary: | summary |