Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K150880 |
Device Name |
Tablo Console with Wireless Capability |
Applicant |
Outset Medical |
1830 Bering Drive |
San Jose,
CA
95112
|
|
Applicant Contact |
Nancy Gallo |
Correspondent |
Outset Medical |
1830 Bering Drive |
San Jose,
CA
95112
|
|
Correspondent Contact |
Nancy Gallo |
Regulation Number | 876.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/01/2015 |
Decision Date | 05/01/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|