Device Classification Name |
solution-test standard-conductivity, dialysis
|
510(k) Number |
K191496 |
Device Name |
TDS Standard Solution |
Applicant |
Mesa Laboratories, Inc. |
12100 West 6th Avenue |
Lakewood,
CO
80228
|
|
Applicant Contact |
Jamie Louie |
Correspondent |
Mesa Laboratories, Inc. |
12100 West 6th Avenue |
Lakewood,
CO
80228
|
|
Correspondent Contact |
Jamie Louie |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 06/05/2019 |
Decision Date | 08/05/2019 |
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
|
|
|