Device Classification Name |
Meter, Conductivity, Non-Remote
|
510(k) Number |
K050812 |
Device Name |
90XL INSTRUMENTATION SYSTEM |
Applicant |
MESA LABORATORIES, INC. |
12100 WEST 6TH AVE. |
LAKEWOOD,
CO
80228
|
|
Applicant Contact |
TODD ROMERO |
Correspondent |
MESA LABORATORIES, INC. |
12100 WEST 6TH AVE. |
LAKEWOOD,
CO
80228
|
|
Correspondent Contact |
TODD ROMERO |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 03/31/2005 |
Decision Date | 05/05/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|