Device Classification Name |
Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
|
510(k) Number |
K141752 |
FOIA Releasable 510(k) |
K141752
|
Device Name |
NXSTAGE SYSTEM ONE |
Applicant |
NXSTAGE MEDICAL, INC. |
350 MERRIMACK STREET |
LAWRENCE,
MA
01843
|
|
Applicant Contact |
MARY LOU STROUMBOS |
Correspondent |
NXSTAGE MEDICAL, INC. |
350 MERRIMACK STREET |
LAWRENCE,
MA
01843
|
|
Correspondent Contact |
MARY LOU STROUMBOS |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 06/30/2014 |
Decision Date | 12/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00667511
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|