The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage System One.
| Device ID | K030470 |
| 510k Number | K030470 |
| Device Name: | NXSTAGE SYSTEM ONE |
| Classification | System, Dialysate Delivery, Sealed |
| Applicant | NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 Lawrence, MA 01843 |
| Contact | Norma Lemay |
| Correspondent | Donald J Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FII |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-02-12 |
| Decision Date | 2003-07-07 |
| Summary: | summary |