The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage System One.
Device ID | K150472 |
510k Number | K150472 |
Device Name: | NxStage System One |
Classification | Ultrafiltration-controlled Nocturnal Dialysate Delivery System |
Applicant | NXSTAGE MEDICAL, INC. 350 MERRIMACK STREET Lawrence, MA 01843 |
Contact | Mary Lou Stroumbos |
Correspondent | Mary Lou Stroumbos NXSTAGE MEDICAL, INC. 350 MERRIMACK STREET Lawrence, MA 01843 |
Product Code | ODN |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-23 |
Decision Date | 2015-06-04 |
Summary: | summary |