Device Classification Name |
System, Dialysate Delivery, Single Patient
|
510(k) Number |
K181991 |
Device Name |
NxStage Connected Health System |
Applicant |
NxStage Medical, Inc |
350 Merrimack Street |
Lawrence,
MA
01843
|
|
Applicant Contact |
Christina Marabella |
Correspondent |
NxStage Medical, Inc |
350 Merrimack Street |
Lawrence,
MA
01843
|
|
Correspondent Contact |
Christina Marabella |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 07/26/2018 |
Decision Date | 09/26/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|