The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage Dialysate Preparation Module, Model Nx0269.
| Device ID | K043436 |
| 510k Number | K043436 |
| Device Name: | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 |
| Classification | Subsystem, Proportioning |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 Lawrence, MA 01843 |
| Contact | Norma Lemay |
| Correspondent | Norma Lemay NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 Lawrence, MA 01843 |
| Product Code | FKR |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-13 |
| Decision Date | 2005-03-17 |
| Summary: | summary |