Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K200741 |
Device Name |
Tablo Hemodialysis System |
Applicant |
Outset Medical, Inc. |
1830 Bering Drive |
San Jose,
CA
95112
|
|
Applicant Contact |
Jennifer Mascioli-Tudor |
Correspondent |
Outset Medical, Inc. |
1830 Bering Drive |
San Jose,
CA
95112
|
|
Correspondent Contact |
Jennifer Mascioli-Tudor |
Regulation Number | 876.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/23/2020 |
Decision Date | 03/31/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02460263
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|